Abstract
Heart failure with preserved ejection fraction (HFpEF), a highly prevalent and complex clinical syndrome with high morbidity and mortality, is often unrecognized and not optimally treated. Clinical trials for HFpEF have been plagued by low enrollment, and clinicians often approach HFpEF patients with “therapeutic nihilism” given the perceived lack of available therapies based on the disappointing results of these prior trials. Due to these challenges, we have pioneered the successful creation of dedicated, specialized HFpEF clinical programs. Here, we discuss (1) the rationale for the development of a specialized HFpEF clinical program; (2) strategies for the systematic identification of HFpEF patients; (3) a standardized diagnostic and therapeutic approach; (4) validation of the HFpEF clinical program paradigm; (5) staffing and reimbursement considerations; (6) HFpEF clinical trial enrollment; and (7) challenges and future directions for HFpEF clinical programs. We conclude that it is feasible to create HFpEF clinical programs that fulfill the major unmet need of identifying and caring for patients with HFpEF. These clinics are essential for confirming the HFpEF diagnosis, providing standardized treatment, and facilitating clinical trial enrollment. It is our hope that the information provided here will encourage others to establish their own specialized HFpEF programs, thereby allowing for comprehensive care for these complex patients.
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Acknowledgments
American Heart Association (0835488 N, 16SFRN28780016, and 15CVGPSD27260148) and National Institutes of Health (R01 HL107557 and R01 HL127028) to SJS.
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Sanjiv J. Shah has received grant support from Actelion, Novartis, and AstraZeneca and consulting fees from Alnylam, AstraZeneca, Bayer, Merck, Novartis, Pfizer, and Sanofi.Rebecca Cogswell, John J. Ryan, and Kavita Sharma declare that they have no conflict of interest.
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Shah, S.J., Cogswell, R., Ryan, J.J. et al. How to Develop and Implement a Specialized Heart Failure with Preserved Ejection Fraction Clinical Program. Curr Cardiol Rep 18, 122 (2016). https://doi.org/10.1007/s11886-016-0802-1
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DOI: https://doi.org/10.1007/s11886-016-0802-1