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Recruiting

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

Updated: 25 May, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the trial 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

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 4

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: HNO Donor, NTG, Placebo

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 ≥ 300 pg/mL (35 pmol/L) or BNP ≥ 100 pg/mL (29 pmol/L) Exclusion Criteria: - Systolic blood pressure (SBP) < 115 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 - 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