Developing Therapies for Heart Failure With Preserved Ejection FractionCurrent State and Future Directions
Author + information
- Javed Butler, MD, MPH1,∗ (javed.butler{at}emory.edu),
- Gregg C. Fonarow, MD2,
- Michael R. Zile, MD3,
- Carolyn S. Lam, MD4,
- Lothar Roessig, MD5,
- Erik B. Schelbert, MD, MS6,
- Sanjiv J. Shah, MD7,
- Ali Ahmed, MD8,
- Robert O. Bonow, MD7,
- John G.F. Cleland, MD9,
- Robert J. Cody, MD, MBA10,
- Ovidiu Chioncel, MD, PhD11,
- Sean P. Collins, MD12,
- Preston Dunnmon, MD13,
- Gerasimos Filippatos, MD14,
- Martin P. Lefkowitz, MD15,
- Catherine N. Marti, MD1,
- John J. McMurray, MD16,
- Frank Misselwitz, MD5,
- Savina Nodari, MD17,
- Christopher O'Connor, MD18,
- Marc A. Pfeffer, MD19,
- Burkert Pieske, MD20,
- Bertram Pitt, MD21,
- Giuseppe Rosano, MD22,
- Hani N. Sabbah, PhD23,
- Michele Senni, MD24,
- Scott D. Solomon, MD19,
- Norman Stockbridge, MD, PhD13,
- John R. Teerlink, MD25,
- Vasiliki V. Georgiopoulou, MD1 and
- Mihai Gheorghiade, MD7
- 1Department of Medicine, Emory Cardiovascular Clinical Research Institute, Emory University, Atlanta, Georgia
- 2Department of Medicine, University of California, Los Angeles, California
- 3Division of Cardiology, Medical University of South Carolina, and RHJ Department of Veterans Affairs Medical Center, Charleston, South Carolina
- 4Cardiovascular Research Institute, National University Health System, Singapore
- 5Global Clinical Development, Bayer HealthCare AG, Wuppertal, Germany
- 6Department of Medicine, University of Pittsburgh Medical Center Heart and Vascular Institute, Pittsburgh, Pennsylvania
- 7Department of Medicine, Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, Illinois
- 8Division of Gerontology, University of Alabama at Birmingham, Birmingham, Alabama
- 9Department of Cardiology, Castle Hill Hospital, Hull York Medical School, Kingston-Upon-Hull, England
- 10Cardiovascular & Metabolism Division, Janssen Pharmaceuticals, Raritan, New Jersey
- 11Institute of Emergency for Cardiovascular Diseases, Cardiology, Bucharest, Romania
- 12Department of Emergency Medicine, Vanderbilt University, Nashville, Tennessee
- 13Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
- 14Department of Cardiology, Athens University Hospital, Attikon, Athens, Greece
- 15Novartis Pharmaceuticals Inc., East Hanover, New Jersey
- 16British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland
- 17Division of Cardiology, University of Brescia, Brescia, Italy
- 18Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
- 19Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts
- 20Department of Cardiology, Medical University Graz, Graz, Austria
- 21Division of Cardiology, Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan
- 22Centre for Clinical and Basic Science, San Raffaele-Roma, Rome, Italy
- 23Department of Medicine, Henry Ford Hospital, Detroit, Michigan
- 24Cardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy
- 25University of California San Francisco and San Francisco Veterans Affairs Medical Center, San Francisco, California
- ↵∗Reprint requests and correspondence:
Dr. Javed Butler, Emory Clinical Cardiovascular Research Institute, 1462 Clifton Road Northeast, Suite AT 504, Atlanta, Georgia 30322.
Abstract
The burden of heart failure with preserved ejection fraction (HFpEF) is considerable and is projected to worsen. To date, there are no approved therapies available for reducing mortality or hospitalizations for these patients. The pathophysiology of HFpEF is complex and includes alterations in cardiac structure and function, systemic and pulmonary vascular abnormalities, end-organ involvement, and comorbidities. There remain major gaps in our understanding of HFpEF pathophysiology. To facilitate a discussion of how to proceed effectively in future with development of therapies for HFpEF, a meeting was facilitated by the Food and Drug Administration and included representatives from academia, industry, and regulatory agencies. This document summarizes the proceedings from this meeting.
Footnotes
The opinions and information in this article are those of the authors, and do not represent the views and/or policies of the U.S. Food and Drug Administration. Dr. Fonarow has served as a consultant for Novartis, Medtronic, and Gambro, and has received research support from Gambro, the National Institutes of Health, and the Agency for Healthcare Research and Quality. Dr. Zile has received research support from NHLBI, VA, Alere, Bayer, CVRx, Medtronic, Novartis, Sanofi-Aventis; and has served as a consultant for Abbott, Alere, Bayer, BG Med, BMS, Cardiome, Celledon, CorAssist, CVRx, GE Health, HDL, Idenex, Intersection Medical, Medtronic, MicroVide, Novartis, ONO Pharma, Sanofi-Aventis, and Up-To-Date. Dr. Lam has served as a consultant for Bayer and Novartis and has received research grant support from Boston Scientific, Medtronic, and Vifor Pharma. Dr. Roessig is an employee of Bayer Pharma. Dr. Schelbert received a Prohance contrast as a gift from Bracco for research purposes. Dr. Cleland has received research funding from Amgen and honoraria from Novartis. Dr. Cody is an employee of Janssen R&D. Dr. Collins has served as a consultant for Novartis, Radiometer, Medtronic, The Medicines Company, Trevena, and Thermo-Fisher Scientific. Dr. Filippatos has served on the steering committee in trials sponsored by Bayer and Corthera. Dr. Lefkowitz is an employee of Novartis. Dr. McMurray was a committee member and co-principal investigator for the PARAGON-HF trial with LCZ696 in HF-PEF, which was sponsored by Novartis. Dr. Misselwitz is an employee of and owns stock for Bayer. Dr. Pfeffer has served as a consultant for Aastrom, Amgen, Bristol-Myers-Squibb, Cerenis, Concert, Genzyme, Hamilton Health Sciences, Keryx, Medtronic, Merck, Novartis, Roche, Servier, Teva, the University of Oxford, and Xoma. Dr. Pieske has received honoraria from Bayer, Servier, Medtronic, Menarini, Daiichi-Sankyo, and Boehringer Ingelheim. Dr. Pitt has served as a consultant for Pfizer, Bayer, Relypsa, Stealth Peptides, and Mesoblast. Dr. Solomon has received research support from and has served as a consultant for Novartis and Bayer. Dr. Teerlink has received research support and consulting fees from Novartis. Dr. Gheorghiade has served as a consultant for Novartis, Bayer, Takeda, and Janssen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 17, 2013.
- Revision received October 1, 2013.
- Accepted October 16, 2013.
- American College of Cardiology Foundation
