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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:January 13, 2017
End Date:August 26, 2019
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients With Heart Failure and Impaired Systolic Function

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


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 found this trial at
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-260-0086
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
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6071 West Outer Drive
Detroit, Michigan 48235
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
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Birmingham, Alabama 35294
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Chapel Hill, North Carolina 27599
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Phone: 434-243-7375
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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Columbus, Ohio 43210
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
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Detroit, Michigan 48202
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Detroit, Michigan 48202
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Detroit, Michigan 48201
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Durham, North Carolina 27710
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Falls Church, Virginia 22042
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1504 Taub Loop
Houston, Texas 77030
(713) 873-2000
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Indianapolis, Indiana 46202
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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1020 Walnut St
Philadelphia, Pennsylvania 19107
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