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Active, Not Recruiting

A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function - CV013-020

Updated: 01 April, 2019   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2


  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
Experimental: BMS-986231/NTG/Placebo
Drug: HNO Donor Drug: Nitroglycerin (NTG) Other: Placebo
Experimental: BMS-986231/Placebo/NTG
Drug: HNO Donor Drug: Nitroglycerin (NTG) Other: Placebo
Experimental: NTG/BMS-986231/Placebo
Drug: Nitroglycerin (NTG) Drug: HNO Donor Other: Placebo
Experimental: NTG/Placebo/BMS-986231
Drug: Nitroglycerin (NTG) Drug: HNO Donor Other: Placebo
Experimental: Placebo/BMS-986231/NTG
Drug: HNO Donor Other: Placebo Drug: Nitroglycerin (NTG)
Experimental: Placebo/NTG/BMS-986231
Drug: HNO Donor Other: Placebo Drug: Nitroglycerin (NTG)

Key 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

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