Trends in Heart Failure Clinical Trials From 2001-2012.

Published

Journal Article (Review)

A systematic assessment of the temporal trends in heart failure (HF) clinical trials is lacking.A total of 154 phase II-IV HF trials including 162,725 patients published from 2001 to 2012 in 8 high-impact-factor journals were reviewed. The median number of participants and sites per trial were 367 (interquartile range [IQR] 133-1450) and 38 (5-101), respectively. Median enrollment duration was 2.2 (1.5-3.3) years. The majority of studies investigated treatment for chronic HF (82.5%) and investigated HF with reduced ejection fraction (EF) (71.4%), whereas 27 trials (17.5%) enrolled patients with mixed EF and 9 (5.8%) enrolled HF with preserved EF patients alone. Enrollment rates did not significantly change over time (median 0.49 patients site(-1) month(-1), IQR 0.34-0.98; P = .53). Trials meeting their primary end point decreased over time from 73.5% in 2001-2003 to 52.5% in 2010-2012 (P = .08) and were more often smaller and used nonmortality end points. Industry trials were larger with shorter enrollment duration, more concentrated in North America, and more likely to be positive. Trials conducted exclusively outside North America and Western Europe had the highest enrollment rates (median 1.95 patients site(-1) month(-1), IQR 1.34-4.11).Contemporary HF clinical trials display slow enrollment rates and decreased rates of positive outcomes over time. Positive trials tended to be smaller size with a higher proportion of surrogate end points.

Full Text

Duke Authors

Cited Authors

  • Samman Tahhan, A; Vaduganathan, M; Kelkar, A; Georgiopoulou, VV; Kalogeropoulos, AP; Greene, SJ; Fonarow, GC; Gheorghiade, M; Butler, J

Published Date

  • March 2016

Published In

Volume / Issue

  • 22 / 3

Start / End Page

  • 171 - 179

PubMed ID

  • 26106806

Pubmed Central ID

  • 26106806

Electronic International Standard Serial Number (EISSN)

  • 1532-8414

International Standard Serial Number (ISSN)

  • 1071-9164

Digital Object Identifier (DOI)

  • 10.1016/j.cardfail.2015.06.014

Language

  • eng