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Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure - CV013-011

Updated: 29 July, 2019   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's 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

  • 67


  • Recruiting

Treatment Options

Study Arms
Experimental: Part 1 Cohort 1 HNO Donor
Drug: HNO Donor
Experimental: Part 2 Cohort 2 HNO Donor- high dose
Drug: HNO Donor
Experimental: Part 2 Cohort 2 HNO Donor- low dose
Drug: HNO Donor
Placebo Comparator: Placebo Part 1 Cohort 1
Drug: Placebo
Placebo Comparator: Placebo Part 2 Cohort 2
Drug: Placebo

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Actively being hospitalized for acute decompensated heart failure - At least 1 administration of IV diuretic for the current episode - Be randomized within 18 hours of first dose of IV diuretic for current episode for Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II - Have shortness of breath at rest or with minimal exertion after administration of 1 dose of IV diuretic - Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40% Exclusion Criteria: - Systolic blood pressure <105mm Hg or >160mm Hg or heart rate <50 or >130 bpm - Have an active infection requiring IV anti-microbial treatment - Be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening - Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening - Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis) Other protocol defined inclusion/exclusion criteria could apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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