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

Updated: 03 December, 2018   |   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.

Do You Fit This Criteria?

Detailed information regarding this trial is below, but the following may help determine if you are eligible.

  • You have experienced heart failure and you have been told by your doctor that you have impaired contractility, or reduced ejection fraction less than or equal to 40%. (your heart has a weak pump)
  • Have stable chronic medications (your prescriptions have not changed in 2 weeks)
  • Be in sinus rhythm, not having arrhythmia such as atrial fibrillation (Your heart does not have extra or irregular beats)
  • Have not been hospitalized for heart problems in the last 3 months
  • Don’t have low blood pressure (systolic blood pressure less than 115 mmHg)
  • Never had a heart transplant or had an LVAD (Left Ventricular Assist Device) implanted
  • Weigh between 100 and 300 pounds

Trial Details

  • Phase 2


  • Gender(s)

  • 18+

    Age Range

  • 6


  • Recruiting

Treatment Options

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

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us