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Updated: Mar 13, 2026

Lumped-Parameter and Finite Element Modeling of Heart Failure with Preserved Ejection Fraction
Published on: February 13, 2021
Exploring New Endpoints for Patients With Heart Failure With Preserved Ejection Fraction
Javed Butler1, Carine E Hamo2, James E Udelson2
1From 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.
Heart failure with preserved ejection fraction (HFpEF) affects many elderly patients, with no current drugs improving survival. New drug development should also focus on improving patient quality of life and function.
Area of Science:
- Cardiology
- Clinical Pharmacology
- Geriatrics
Background:
- Heart failure (HF) is a growing epidemic with significant health and societal impacts.
- Heart failure with preserved ejection fraction (HFpEF) constitutes approximately 50% of all HF cases.
- HFpEF predominantly affects the elderly population, a demographic expected to increase.
Purpose of the Study:
- To discuss the need for and challenges in developing alternative endpoints for HFpEF drug approval.
- To explore incorporating functional capacity and quality of life metrics into regulatory pathways.
- To foster dialogue among stakeholders regarding HFpEF patient-centric outcomes.
Main Methods:
- A meeting was convened by the US Food and Drug Administration on November 12, 2015.
- Participants included experts from clinical practice, academia, industry, and regulatory agencies.
- The meeting focused on the unmet needs in HFpEF treatment and drug development.
Main Results:
- Current therapies for HFpEF do not improve mortality or reduce hospitalization risk.
- Patients with HFpEF experience substantial declines in functional capacity and quality of life.
- There is a critical need for therapeutic strategies that address these patient-reported outcomes.
Conclusions:
- The development of novel therapies for HFpEF is urgently required.
- Regulatory pathways should consider functional capacity and quality of life as key endpoints.
- Collaborative efforts are essential to advance HFpEF treatment and improve patient well-being.
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