Recruiting
Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure - CV013-011
Updated: 17 January, 2019 | ClinicalTrials.gov
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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