title: Design considerations for clinical trials of autonomic modulation therapies targeting hypertension and heart failure.
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.). f.zannad@chu-nancy.fr.
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.).
authors.forename: Wendy Gattis
authors.initials: WG
authors.lastname: Stough
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.).
authors.forename: Felix
authors.initials: F
authors.lastname: Mahfoud
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.).
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.).
authors.forename: Sverre E
authors.initials: SE
authors.lastname: Kjeldsen
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.).
authors.forename: Robert S
authors.initials: RS
authors.lastname: Kieval
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.).
authors.forename: Hermann
authors.initials: H
authors.lastname: Haller
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.).
authors.forename: Nadim
authors.initials: N
authors.lastname: Yared
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.).
authors.forename: Gaetano M
authors.initials: GM
authors.lastname: De Ferrari
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.).
authors.forename: Ileana L
authors.initials: IL
authors.lastname: Piña
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.).
authors.forename: Kenneth
authors.initials: K
authors.lastname: Stein
authors.affiliation: From the Department of Cardiology, INSERM, Center d'Investigation Clinique 9501 and Unité 961, Center Hospitalier Universitaire, Nancy University, Université de Lorraine, Nancy, France (F.Z.); Departments of Pharmacy Practice and Clinical Research, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (W.G.S.); Klinik für Innere Medizin III, Universtitätsklinikum des Saarlandes, Homburg/Saar, Germany (F.M.); Harvard-MIT Biomedical Engineering, Institute of Medical Engineering and Science, Cambridge, MA (F.M.); ASH Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.L.B.); Oslo University Hospital, Ullevaal, Institute for Clinical Medicine, University of Oslo, Oslo, Norway (S.E.K.); CVRx, Inc, Minneapolis, MN (R.S.K., N.Y.); Department of Nephrology, Medizinische Hochschule Hannover, Hannover, Germany (H.H.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (G.M.D.F.); Department of Medicine, Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, NY (I.L.P.); Boston Scientific Corporation, St. Paul, MN (K.S.); Université Paris Descartes, Paris, France (M.A.); Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (M.A.); and Inserm CIC 9201, Paris, France (M.A.).
authors.forename: Michel
authors.initials: M
authors.lastname: Azizi
mesh_terms: D001341:Autonomic Nervous System / Q000503:physiopathology*; D002986:Clinical Trials as Topic / Q000379:methods*; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D006973:Hypertension / Q000503:physiopathology / Q000628:therapy*; D011311:Pressoreceptors / Q000503:physiopathology