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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Cardiac Failure; Heart Decompensation; Myocardial Failure; Congestive Heart Failure

Treatments: Drug: BMS-986231; Drug: Furosemide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03730961

2018-000970-31 (EudraCT Number)

CV013-034

Details and patient eligibility

About

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.

Enrollment: 23 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:

• Left ventricular ejection fraction <45%, as assessed by echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI) scan within 18 months
• On stable chronic guideline-directed therapy for HF including chronic loop diuretics, ACEi, ARBs, MRAs, ARNI or / and β-blockers as tolerated, with no changes of these medications in the past 2 weeks
• At least an oral dose of 40 mg of furosemide/day or equivalent (20 mg torsemide, 1 mg bumetamide)

Exclusion Criteria:

• SBP < 115 mm Hg or > 180 mm Hg at screening or pre-randomization
• Heart rate < 50 beats per minute (bpm) or > 120 bpm at screening or pre-randomization
• Primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic or uncorrected severe valvular disease

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups

Placebo+Diuretic to BMS-986231+Diuretic

Experimental group

Description:

Administered in a cross over design with 8-hour continuous infusions and 7-28 day wash-out periods

Treatment:

Drug: BMS-986231

Drug: Placebo

Drug: Furosemide

BMS-986231+Diuretic to Placebo+Diuretic

Experimental group

Description:

Administered in a cross over design with 8-hour continuous infusions and 7-28 day wash-out periods

Treatment:

Drug: BMS-986231

Drug: Placebo

Drug: Furosemide