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Exploring New Endpoints for Patients With Heart Failure With Preserved Ejection Fraction.
- Source :
-
Circulation. Heart failure [Circ Heart Fail] 2016 Nov; Vol. 9 (11). - Publication Year :
- 2016
-
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.<br /> (© 2016 American Heart Association, Inc.)
- Subjects :
- Congresses as Topic
Drug Approval
Drug Discovery
Exercise Test
Heart Failure physiopathology
Humans
Outcome Assessment, Health Care
Oxygen Consumption
Quality of Life
United States
United States Food and Drug Administration
Walk Test
Heart Failure therapy
Hospitalization
Mortality
Patient Reported Outcome Measures
Stroke Volume
Subjects
Details
- Language :
- English
- ISSN :
- 1941-3297
- Volume :
- 9
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Circulation. Heart failure
- Publication Type :
- Academic Journal
- Accession number :
- 27756791
- Full Text :
- https://doi.org/10.1161/CIRCHEARTFAILURE.116.003358