Natriuretic Peptide-Based Inclusion Criteria in a Heart Failure Clinical Trial Insights From COMMANDER HF

Jonathan W. Cunningham, Joao Pedro Ferreira, Hsiaowei Deng, Stefan D. Anker, William M. Byra, John G. F. Cleland, Mihai Gheorghiade, Carolyn S. P. Lam, David La Police, Mandeep R. Mehra, James D. Neaton, Theodore E. Spiro, Dirk J. van Veldhuisen, Barry Greenberg, Faiez Zannad*

*Bijbehorende auteur voor dit werk

OnderzoeksoutputAcademicpeer review

8 Citaten (Scopus)

Samenvatting

OBJECTIVES This study investigated the effects of a mid-trial protocol amendment requiring elevated natriuretic peptides for inclusion in the COMMANDER-HF (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure) trial.

BACKGROUND Heart failure (HF) trials that select patients based on history of HF hospitalization atone are susceptible to regional variations in event rates. Elevated plasma concentrations of natriuretic peptides (NPs) as selection criteria may help HF ascertainment and risk enrichment. In the COMMANDER-HF trial, B-type natriuretic peptide >= 200 ng/l or N-terminal pro-B-type natriuretic peptide >= 800 ng/l were added to inclusion criteria as a mid-trial protocol amendment, providing a unique case-study of NP-based inclusion criteria.

METHODS We compared the baseline characteristics, event rates, and treatment effects for patients enrolled before and after the NP protocol amendment. The primary endpoint was all-cause death, myocardial infarction, or stroke. Secondary endpoints included HF rehospitalization and cardiovascular death.

RESULTS A total of 5,022 patients with left ventricular ejection fraction

CONCLUSIONS In a global event-driven trial of rivaroxaban in HF, requiring elevated NPs for inclusion increased event rates allowing earlier completion of the trial but did not modify treatment effect. These data inform future HF trials regarding the expected impact of NP-based inclusion criteria on patient characteristics and event rates. (COMMANDER HF [A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure] (C) 2020 by the American College of Cardiology Foundation.

Originele taal-2English
Pagina's (van-tot)359-368
Aantal pagina's10
TijdschriftJACC. Heart failure
Volume8
Nummer van het tijdschrift5
DOI's
StatusPublished - mei-2020

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