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

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID

NCT03016325

Run by

Bristol-Myers Squibb

People needed

329

Starts

2017-01-13

Expected to finish

2019-11-12

Last updated by the study team

2021-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• DMC Detroit Receiving Hospital — Detroit, Michigan, United States
• Harper University Hospital — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Sinai Grace Hospital — Detroit, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Wexner Medical Center at The Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina - PPDS — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Ben Taub General Hospital — Houston, Texas, United States
• University of Utah Medical Center — Salt Lake City, Utah, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Local Institution — CABA, Buenos Aires, Argentina
• University of Arizona Sarver Heart Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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