Facebook Icon Print Created with Sketch. Twitter Icon Created with Sketch. Created with Sketch. LinkedIn Icon Green Check Icon Created with Sketch. YouTube Icon Right Arrow Icon Mobile Menu Icon Chevron Right Icon Phone Icon Health Study Area: AutoImmune Disease Health Study Area: Blood Cancer Health Study Area: Cardiovascular Disease Health Study Area: Fibrosis Health Study Area: Gastrointestinal Cancer Health Study Area: Genitourinary Health Study Area: Head and Neck Cancer Health Study Area: Lung Cancer Health Study Area: Melanoma For Caregivers For Clinicians Communities FAQs For Parents For Patients Chevron Icon Bookmark Icon Map Icon Share Icon Direction Arrow Icon Direction Arrow Icon Page Icon Location Icon Search Icon External Link Icon Help Icon Error Icon Glossary Email Icon Gender Both Gender Male Gender Female Created with Sketch. Created with Sketch.

Please Log In/Join Now first, and then use this function!

Recruiting

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

CONSIDERING THIS TRIAL?
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

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 6

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
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