Covariate adjustment in heart failure randomized controlled clinical trials: a case analysis of the HF-ACTION trial.


Journal Article (Review)

Randomized controlled clinical trials are predominantly used to determine the benefit of a therapeutic intervention in patients with congestive heart failure (HF). These trials are commonly lengthy and expensive, and enroll patients with baseline imbalances that may influence outcome, even after randomization. Methods allowing for greater precision, power, and adjustment for treatment effect would be welcomed. Covariate adjustment may provide more individualized effect estimates and a potential improvement in power and reduction in type 1 error. This article reviews the HF-ACTION trial to better understand whether covariate adjustment should be prespecified as the primary end point in HF clinical trials.

Full Text

Duke Authors

Cited Authors

  • O'Connor, CM; Mentz, RJ; Whellan, DJ

Published Date

  • October 2011

Published In

Volume / Issue

  • 7 / 4

Start / End Page

  • 497 - 500

PubMed ID

  • 21925432

Pubmed Central ID

  • 21925432

International Standard Serial Number (ISSN)

  • 1551-7136

Digital Object Identifier (DOI)

  • 10.1016/j.hfc.2011.06.011


  • eng

Conference Location

  • United States