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

• Status: Completed
• Trial end date: 2019-05-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Nitroglycerin

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