An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic

Phase 2 Completed 23 enrolled Bristol-Myers Squibb

RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to investigate continuous 8-hour introductions of BMS-986231 in participants with heart failure and weakened heart function given a standard dose of diuretic.

Timeline

Start: 2019-01-17
Primary completion: 2019-12-11
Completion: 2020-01-09

Outcome

Missed primary endpoint

registry analysis (superiority test); BMS-986231 vs Placebo; p = 0.0021; Mean Difference (Net) -448 (95% CI -714 to -183); t-test, 2 sided NCT03730961 ↗

Publications

Felker GM, Borentain M, Cleland JG, DeSouza MM, Kessler PD, O'Connor CM, Seiffert D, Teerlink JR, Voors AA, McMurray JJV. Rationale and design for the development of a novel nitroxyl donor in patients with acute heart failure. Eur J Heart Fail. 2019 Aug;21(8):1022-1031. doi: 10.1002/ejhf.1504. Epub 2019 Jun 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	cimlanod	Other / unclassified	—	Intravenous
Background	Furosemide	Other / unclassified	—	Intravenous