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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.
Abstract:
The epidemiological, clinical, and societal implications of the heart failure (HF) epidemic cannot be overemphasized. Approximately half of all HF patients have HF with preserved ejection fraction (HFpEF). HFpEF is largely a syndrome of the elderly, and with aging of the population, the proportion of patients with HFpEF is expected to grow. Currently, there is no drug known to improve mortality or hospitalization risk for these patients. Besides mortality and hospitalization, it is imperative to realize that patients with HFpEF have significant impairment in their functional capacity and their quality of life on a daily basis, underscoring the need for these parameters to ideally be incorporated within a regulatory pathway for drug approval. Although attempts should continue to explore therapies to reduce the risk of mortality or hospitalization for these patients, efforts should also be directed to improve other patient-centric concerns, such as functional capacity and quality of life. To initiate a dialogue about the compelling need for and the challenges in developing such alternative endpoints for patients with HFpEF, the US Food and Drug Administration on November 12, 2015, facilitated a meeting represented by clinicians, academia, industry, and regulatory agencies. This document summarizes the discussion from this meeting.
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