A Phase 2 study of BMS-986231 in Patients with Heart Failure

Phase 2

Completed

• Conditions: Chronic Heart Failure

• Registration Number: JPRN-jRCT2080223738
• Lead Sponsor: Bristol-Myers Squibb K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-05
• Study Completion: 2019-05-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Signed Written Informed Consent
Age 20 years (or age of majority) or older
Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less), as assessed by the echocardiographic corelab.
Stable guideline directed therapy for heart failure (could include oral diuretics, ACEi, ARBs, ARNi, MRAs , and B blockers as tolerated), with no dose changes of these medications in the past 2 weeks
Have screening values of NT pro-BNP over 300 pg/mL (35 pmol/L) or BNP over 100 pg/mL (29 pmol/L).
In sinus rhythm at the start of the infusion

Exclusion Criteria

Body weight < 45 kg or over 140 kg
Low quality echocardiographic visualization windows and image acquisition
Systolic blood pressure (SBP) < 115 mm Hg at screening or pre-randomization
Heart rate < 50 beats per minute (bpm) or > 90 bpm at screening or pre-randomization
Permanent Atrial Fibrillation, Atrial Flutter or having Atrial Fibrillation, Atrial Flutter before start of the infusion
Paced rhythm (VVI, DDD or BiV pacing)
Ventricular assist device or prior heart transplant
Primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic or uncorrected severe valvular disease as defined by AHA/ACC/ESC criteria.
Treatment with intravenous inotropic therapy (dobutamine, milrinone, leveosimendan) in the
previous month or planned treatment in the next 3 months.
Current treatment with chronic oral, transdermal or sublingual nitrates

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>Mean SVI derived from the velocity time integral at the left ventricular outflow tract (LVOT VTI) at the end of the 5-hours infusion of BMS-986231, versus placebo.

Secondary Outcome Measures

Name	Time	Method
safety<br>exploratory<br>pharmacokinetics<br>pharmacodynamics<br>pharmacogenomics<br>Mean SVI derived from LVOT VTI at the end of the 5-hours infusion of BMS 986231, versus NTG.<br>Mean LVEF, computed by Simpson's method at the end of the 5-hours infusion of BMS-986231, versus placebo and NTG.