Vanderbilt Clinical Trials

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		Drug: HNO Donor Infusion Other names: BMS-986231
Placebo Comparator Placebo Part 1 Cohort 1		Drug: Placebo Infusion
Experimental Part 2 Cohort 2 HNO Donor- low dose		Drug: HNO Donor Infusion Other names: BMS-986231
Experimental Part 2 Cohort 2 HNO Donor- high dose		Drug: HNO Donor Infusion Other names: BMS-986231
Placebo Comparator Placebo Part 2 Cohort 2		Drug: Placebo Infusion

More Details

Status: Completed
Sponsor: Bristol-Myers Squibb

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.