Patient selection in heart failure with preserved ejection fraction clinical trials.


Journal Article (Review)

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.

Full Text

Duke Authors

Cited Authors

  • Kelly, JP; Mentz, RJ; Mebazaa, A; Voors, AA; Butler, J; Roessig, L; Fiuzat, M; Zannad, F; Pitt, B; O'Connor, CM; Lam, CSP

Published Date

  • April 28, 2015

Published In

Volume / Issue

  • 65 / 16

Start / End Page

  • 1668 - 1682

PubMed ID

  • 25908073

Pubmed Central ID

  • 25908073

Electronic International Standard Serial Number (EISSN)

  • 1558-3597

Digital Object Identifier (DOI)

  • 10.1016/j.jacc.2015.03.043


  • eng

Conference Location

  • United States