title: Patient selection in heart failure with preserved ejection fraction clinical trials.
abstract: Recent clinical trials in patients with heart failure with preserved ejection fraction (HFpEF) have provided important insights into participant selection strategies. Historically, HFpEF trials have included patients with relatively preserved left ventricular ejection fraction ranging from 40% to 55% and a clinical history of heart failure. Contemporary HFpEF trials have also incorporated inclusion criteria such as hospitalization for HFpEF, altered functional capacity, cardiac structural and functional abnormalities, and abnormalities in neurohormonal status (e.g., elevated natriuretic peptide levels). Careful analyses of the effect of these patient selection criteria on outcomes in prior trials provide valuable lessons for future trial design. We review recent and ongoing HFpEF clinical trials from a patient selection perspective and appraise trial patient selection methodologies in relation to outcomes. This review reflects discussions between clinicians, scientists, trialists, regulators, and regulatory representatives at the 10th Global CardioVascular Clinical Trialists Forum in Paris, France, on December 6, 2013.
authors.affiliation: Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina. Electronic address: jacob.kelly@dm.duke.edu.
authors.forename: Jacob P
authors.initials: JP
authors.lastname: Kelly
authors.affiliation: Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mentz
authors.affiliation: Department of Anesthesia and Critical Care, University Paris Diderot, Sorbonne Paris Cité, Paris, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Mebazaa
authors.affiliation: Department of Cardiology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.
authors.forename: Adriaan A
authors.initials: AA
authors.lastname: Voors
authors.affiliation: Cardiology Division, Stony Brook University, Stony Brook, New York.
authors.forename: Javed
authors.initials: J
authors.lastname: Butler
authors.affiliation: Global Clinical Development, Bayer Pharma AG, Berlin, Germany.
authors.forename: Lothar
authors.initials: L
authors.lastname: Roessig
authors.affiliation: Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
authors.forename: Mona
authors.initials: M
authors.lastname: Fiuzat
authors.affiliation: INSERM, Centre d'Investigations Cliniques, Université de Lorraine and CHU de Nancy, Nancy, France.
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad
authors.affiliation: University of Michigan School of Medicine, Ann Arbor, Michigan.
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.affiliation: Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: O'Connor
authors.affiliation: Department of Cardiology, National Heart Centre Singapore, Singapore.
authors.forename: Carolyn S P
authors.initials: CSP
authors.lastname: Lam
mesh_terms: D001281:Atrial Fibrillation / Q000150:complications; D002986:Clinical Trials as Topic; D006333:Heart Failure / Q000175:diagnosis*; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D045265:Natriuretic Peptides / Q000097:blood; D018579:Patient Selection; D013318:Stroke Volume
chemical_list: D045265:Natriuretic Peptides
keywords: clinical protocols; methodology; natriuretic peptides; patient selection