Patient selection in heart failure with preserved ejection fraction clinical trials
Open accessAbstract
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.
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Natriuretic peptide levels are part of the diagnostic assessment of HFpEF, although natriuretic peptide levels are elevated in AF patients and the optimum diagnostic cut-off is still unknown.
“Natriuretic peptide levels are part of the diagnostic assessment of HFpEF, 222 although natriuretic peptide levels are elevated in AF patients and the optimum diagnostic cut-off is still unknown.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [235]
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References 101 · Cited by 139
Research works printed but not linked: 1
- [17]Mentz RJ Kelly JP von Lueder TG Noncardiac comorbidities in heart failure with reduced versus preserved ejection fraction J Am Coll Cardiol 2014 64 2281 2293 25456761 PMC4254505
- Authors
- Kelly, J. P., Mentz, R. J., Mebazaa, A., Voors, A. A., Butler, J., Roessig, L., Fiuzat, M., Zannad, F., Pitt, B., O’Connor, C. M., & Lam, C. S. P.
- Affiliations
- Duke University (US)
- Duke Medical Center (US)
- Sorbonne Paris Cité (FR)
- University Medical Center Groningen (NL)
- Stony Brook University (US)
- Bayer (Germany) (DE)
- Inserm (FR)
- University of Michigan (US)
- National Heart Centre Singapore (SG)
- Corresponding author
- Kelly, Jacob P.
- ORCID
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2015-04
- Volume
- 65
- Issue
- 16
- Pages
- 1668-1682
- ISSN
- 0735-1097 (ISSN-L)
- PMC
- PMC4713836
- OpenAlex
- W2129043636
- Cited by
- 139
- References
- 101
- Citations by year
- 2026: 4 · 2025: 3 · 2024: 10 · 2023: 14 · 2022: 9 · 2021: 16 · 2020: 15 · 2019: 16 · 2018: 14 · 2017: 12 · 2016: 21 · 2015: 5
- FWCI
- 2.99
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- HAL (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Funders
- Amgen
- Bristol-Myers Squibb
- AstraZeneca
- Gilead Sciences
- Thoratec Corporation
- Alere
- Boston Scientific Corporation
- HeartWare
- BG Medicine
- ResMed
- Bayer HealthCare
- National Institutes of Health (5 T32 HL)
- Relypsa
- National Heart, Lung, and Blood Institute (T32HL007101, 5 T32 HL 7101-39)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
- Health Sciences › Medicine › Complementary and alternative medicine › Cardiovascular and exercise physiology
- Keywords
- heart failure with preserved ejection fraction, patient selection, trial inclusion criteria, trial design, natriuretic peptides, left ventricular ejection fraction, heart failure hospitalization, functional capacity, cardiac structural abnormalities, trial outcomes
- MeSH terms
- Atrial Fibrillation, Clinical Trials as Topic, Heart Failure, Hemodynamics, Humans, Stroke Volume, Patient Selection, Natriuretic Peptides
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