A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function

Phase 2 Completed 49 enrolled Bristol-Myers Squibb

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effects of BMS-986231 on systolic and diastolic parameters in patients with heart failure and low ejection fraction.

Timeline

Start: 2017-11-30
Primary completion: 2019-05-10
Completion: 2019-05-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo (PBO) vs BMS-986231; p = 0.027; Mean Difference (Net) -2.150 (95% CI -4.0432 to -0.2570); Kenward-Roger degree of freedom NCT03357731 ↗

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	Nitroglycerin	Unknown	—	—
Subject	cimlanod	Other / unclassified	—	Intravenous