title: How to Develop and Implement a Specialized Heart Failure with Preserved Ejection Fraction Clinical Program.
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.
authors: Department of Medicine, Division of Cardiology, Northwestern University Feinberg School of Medicine, 676 N. St. Clair St., Suite 600, Chicago, IL, 60611, USA. sanjiv.shah@northwestern.edu.
authors: Sanjiv J
authors: SJ
authors: Shah
authors: Division of Cardiology, University of Minnesota, Minneapolis, MN, USA.
authors: Rebecca
authors: R
authors: Cogswell
authors: Department of Medicine, Division of Cardiovascular Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA.
authors: John J
authors: JJ
authors: Ryan
authors: Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors: Kavita
authors: K
authors: Sharma
mesh_terms: D001281:Atrial Fibrillation / Q000150:complications / Q000175:diagnosis* / Q000503:physiopathology; D002317:Cardiovascular Agents / Q000008:administration & dosage; D006333:Heart Failure / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D015995:Prevalence; D016730:Program Development; D015397:Program Evaluation; D011945:Receptors, Angiotensin / Q000378:metabolism
chemical_list: D002317:Cardiovascular Agents; D011945:Receptors, Angiotensin
keywords: Clinical trials; Diagnosis; Disease management program; Heart failure with preserved ejection fraction; Treatment