Abstract 16258: Clinical Trials in Heart Failure: Where Are We?
Introduction: Heart failure (HF) is a global health problem. We sought to examine the focus of ongoing clinical trials in HF and compare ongoing trials with population prevalence of HF with preserved (HFpEF) and reduced ejection fraction (HFrEF).
Methods: We accessed the National Institutes of Health’s ‘ClinicalTrials.gov’ and the WHO International Clinical Trials registries and identified all registered clinical trials with the search term ’Heart failure’ updated until April 2016. We extracted relevant information on current clinical trials in HF. We pooled available data from major observational cohort studies and computed proportions of HFpEF and HFrEF in the community.
Results: There were 1,956 ongoing registered clinical trials in HF of which 718 met our inclusion criteria. One-half of these trials had clinical endpoints and about a third (31.5%) had imaging endpoints as the primary outcome measure. 23.8% of trials were industry-sponsored, 34.8% were university-sponsored and only 1.8% were funded by the National Institutes of Health. Medical and device therapies were being evaluated in 70.2% and 24.2% of trials respectively; molecular and gene therapies were the focus of 5.7% of the trials. Among the studies in which the data on left ventricular ejection fraction is available, HFrEF was the focus of 84.5% trials and only 15.5% trials targeted HFpEF. In comparison, among participants of 7 major observational cohort studies comprising a total of 21,651 participants, the proportion of HFrEF was 47.4% and HFpEF was 52.6%.
Conclusions: Although HFpEF is as prevalent as HFrEF in the community, ongoing clinical trials on HFpEF are sparse. Majority of HF trials are industry or university-sponsored with only a minor contribution from NIH and other Federal sources. Our findings warrant the need for funding agencies and investigators to prioritize future research efforts on HFpEF to reduce the population burden of HF.
Author Disclosures: N.K. Pothineni: None. A.J. Kattoor: None. S. Kovelamudi: None. S. Kenchaiah: None.
- © 2016 by American Heart Association, Inc.