Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Acute Decompensated Heart Failure

Treatments: Drug: BMS-986259; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04318093

2019-004186-40 (EudraCT Number)

CV019-010

Details and patient eligibility

About

The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Participants currently hospitalized for acute decompensated heart failure (ADHF)
• Participants must be hemodynamically stable, as assessed by the investigator
• Men must agree to follow specific methods of contraception, if applicable, while participating in the trial
• Women participants must have documented proof that they are not of childbearing potential

Exclusion Criteria:

• Acute cardiovascular condition other than heart failure (HF) decompensation
• Cardiogenic shock at presentation to emergency room (ER) or at any time before randomization
• Recipient of ventricular assist devices or use of any cardiac extracorporeal devices, within 12 weeks of study randomization
• Participants with contraindications to vasodilator therapy such as restrictive or obstructive cardiomyopathy, severe mitral or aortic stenosis

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

BMS-986259

Experimental group

Treatment:

Drug: BMS-986259

Placebo

Placebo Comparator group

Treatment:

Other: Placebo