A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Cardiac Failure; Reduced Ventricular Ejection Fraction; Heart Failure

Treatments: Other: Placebo; Drug: Nitroglycerin (NTG); Drug: HNO Donor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03357731

2016-003586-26 (EudraCT Number)

CV013-020

Details and patient eligibility

About

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.

Enrollment: 49 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:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 6 patient groups

Placebo/BMS-986231/NTG

Experimental group

Description:

administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods

Treatment:

Drug: Nitroglycerin (NTG)

Drug: HNO Donor

Other: Placebo

Placebo/NTG/BMS-986231

Experimental group

Description:

administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods

Treatment:

Drug: Nitroglycerin (NTG)

Drug: HNO Donor

Other: Placebo

NTG/Placebo/BMS-986231

Experimental group

Description:

administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods

Treatment:

Drug: Nitroglycerin (NTG)

Drug: HNO Donor

Other: Placebo

NTG/BMS-986231/Placebo

Experimental group

Description:

administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods

Treatment:

Drug: Nitroglycerin (NTG)

Drug: HNO Donor

Other: Placebo

BMS-986231/Placebo/NTG

Experimental group

Description:

administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods

Treatment:

Drug: Nitroglycerin (NTG)

Drug: HNO Donor

Other: Placebo

BMS-986231/NTG/Placebo

Experimental group

Description:

administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods

Treatment:

Drug: Nitroglycerin (NTG)

Drug: HNO Donor

Other: Placebo