Chronic Heart Failure
Conditions
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Body weight 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy 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
| Measure | Time frame |
|---|---|
| safety exploratory pharmacokinetics pharmacodynamics pharmacogenomics Mean SVI derived from LVOT VTI at the end of the 5-hours infusion of BMS 986231, versus NTG. Mean LVEF, computed by Simpson's method at the end of the 5-hours infusion of BMS-986231, versus placebo and NTG. | — |
Countries
Europe, Japan, North America
Outcome results
None listed