A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
Heart Failure, Cardiac Failure, Reduced Ventricular Ejection Fraction
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- Orange County Research Center
- Northwestern Medicine
- Indiana University School of Medicine-Indianapolis
- Brigham and Womens Hospital
- Duke Advanced Heart and Lung Failure Clinic
- Inova Heart and Vascular Institute
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo/BMS-986231/NTG
Placebo/NTG/BMS-986231
NTG/Placebo/BMS-986231
NTG/BMS-986231/Placebo
BMS-986231/Placebo/NTG
BMS-986231/NTG/Placebo
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods