A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
A
Abhishek Khemka
Primary Investigator
Not Recruiting
18 years or above
All
Phase
2
49 participants needed
1 Location
Brief description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Heart Failure, Cardiac Failure, Reduced Ventricular Ejection Fraction
-
Age: 18 years or above
-
Gender: All
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less)
- Stable guideline directed therapy for heart failure including oral diuretics, ACEi, ARBs, ARNi, MRAs, and β blockers as tolerated, with no dose changes of these medications in the past 2 weeks
- Have screening values of NT pro-BNP ≥ 125 pg/mL (15 pmol/L) or BNP ≥ 35 pg/mL (10 pmol/L)
Exclusion Criteria:
- Systolic blood pressure (SBP) < 110 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
- Estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73 m2
- Ventricular assist device or prior heart transplant
- Prior solid organ transplant
- Body weight < 45 kg or ≥ 140 kg
- Low quality echocardiographic visualization windows and image acquisition
- Permanent paced rhythm (VVI, DDD or BiV pacing)
Other protocol defined inclusion/exclusion criteria could apply
Updated on
26 Jul 2025.
Study ID: CV013-020
