Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure
Purpose
A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function
Condition
- Heart Failure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1 Cohort 1 HNO Donor |
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Placebo Comparator Placebo Part 1 Cohort 1 |
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Experimental Part 2 Cohort 2 HNO Donor- low dose |
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Experimental Part 2 Cohort 2 HNO Donor- high dose |
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Placebo Comparator Placebo Part 2 Cohort 2 |
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More Details
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb