title: Covariate adjustment in heart failure randomized controlled clinical trials: a case analysis of the HF-ACTION trial.
abstract: 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.
authors.affiliation: Division of Cardiology, Duke University Medical Center, Durham, NC 27710, USA. oconn002@mc.duke.edu
authors.forename: Christopher M
authors.initials: CM
authors.lastname: O'Connor
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mentz
authors.forename: David J
authors.initials: DJ
authors.lastname: Whellan
mesh_terms: D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D016015:Logistic Models; D016032:Randomized Controlled Trials as Topic; D018401:Sample Size; D016896:Treatment Outcome