title: Exploring New Endpoints for Patients With Heart Failure With Preserved Ejection Fraction.
abstract: The epidemiological, clinical, and societal implications of the heart failure (HF) epidemic cannot be overemphasized. Approximately half of all HF patients have HF with preserved ejection fraction (HFpEF). HFpEF is largely a syndrome of the elderly, and with aging of the population, the proportion of patients with HFpEF is expected to grow. Currently, there is no drug known to improve mortality or hospitalization risk for these patients. Besides mortality and hospitalization, it is imperative to realize that patients with HFpEF have significant impairment in their functional capacity and their quality of life on a daily basis, underscoring the need for these parameters to ideally be incorporated within a regulatory pathway for drug approval. Although attempts should continue to explore therapies to reduce the risk of mortality or hospitalization for these patients, efforts should also be directed to improve other patient-centric concerns, such as functional capacity and quality of life. To initiate a dialogue about the compelling need for and the challenges in developing such alternative endpoints for patients with HFpEF, the US Food and Drug Administration on November 12, 2015, facilitated a meeting represented by clinicians, academia, industry, and regulatory agencies. This document summarizes the discussion from this meeting.
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.). javed.butler@stonybrookmedicine.edu.
authors.forename: Javed
authors.initials: J
authors.lastname: Butler
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Carine E
authors.initials: CE
authors.lastname: Hamo
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: James E
authors.initials: JE
authors.lastname: Udelson
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Clyde
authors.initials: C
authors.lastname: Yancy
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Sanjiv J
authors.initials: SJ
authors.lastname: Shah
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Patrice
authors.initials: P
authors.lastname: Desvigne-Nickens
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Harold S
authors.initials: HS
authors.lastname: Bernstein
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Richard L
authors.initials: RL
authors.lastname: Clark
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Christophe
authors.initials: C
authors.lastname: Depre
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Wilfried
authors.initials: W
authors.lastname: Dinh
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Andrew
authors.initials: A
authors.lastname: Hamer
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Patricia
authors.initials: P
authors.lastname: Kay-Mugford
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Frank
authors.initials: F
authors.lastname: Kramer
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Martin
authors.initials: M
authors.lastname: Lefkowitz
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Kelly
authors.initials: K
authors.lastname: Lewis
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Juan
authors.initials: J
authors.lastname: Maya
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Simon
authors.initials: S
authors.lastname: Maybaum
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Mahesh J
authors.initials: MJ
authors.lastname: Patel
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Pia S
authors.initials: PS
authors.lastname: Pollack
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Lothar
authors.initials: L
authors.lastname: Roessig
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Sarit
authors.initials: S
authors.lastname: Rotman
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Afshin
authors.initials: A
authors.lastname: Salsali
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: J Jason
authors.initials: JJ
authors.lastname: Sims
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Michele
authors.initials: M
authors.lastname: Senni
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rosano
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Preston
authors.initials: P
authors.lastname: Dunnmon
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Norman
authors.initials: N
authors.lastname: Stockbridge
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Michael R
authors.initials: MR
authors.lastname: Zile
authors.affiliation: From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (J.E.U.); Division of Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.); Division of Cardiology (C.Y., S.J.S.) and Center for Cardiovascular Innovation (M.G.), Feinberg School of Medicine, Northwestern University, Chicago, IL; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (P.D.-N); Merck & Co, Kenilworth, NJ (H.S.B.); Medtronic, Mounds View, MN (R.L.C., J.J.S.); Amgen Inc, Thousand Oaks, CA (C.D., A.H., J.M.); Bayer Pharma AG, Wuppertal, Germany (W.D., F.K., K.L., L.R., S.R.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); Novartis Pharmaceuticals Inc, East Hanover, NJ (P.K.-M., M.L., S.M.); Clinical Research in Cardiovascular Disease Division, Merck Research Laboratories, Rahway, NJ (M.J.P.); AstraZeneca Global Medicines Development, Gaithersburg, MD (P.S.P.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Dipartimento Cardiovascolare, Azienda Ospedaliera Papa Giovannni XXIII, Bergamo, Italy (M.S.); Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy (G.R.); Cardiovascular and Cell Science Institute, St George's University of London, United Kingdom (G.R.); Division of Cardiovascular and Renal Products, the United States Food and Drug Administration, Silver Spring, MD (P.D., N.S.); Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Germany (S.D.A.); and Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.R.Z.).
authors.forename: Mihai
authors.initials: M
authors.lastname: Gheorghiade
mesh_terms: D003226:Congresses as Topic; D017277:Drug Approval; D055808:Drug Discovery; D005080:Exercise Test; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006760:Hospitalization; D006801:Humans; D009026:Mortality; D017063:Outcome Assessment, Health Care; D010101:Oxygen Consumption; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D013318:Stroke Volume; D014481:United States; D014486:United States Food and Drug Administration; D000070857:Walk Test
keywords: aging; drug approval; heart failure; hospitalization; quality of life