Heart Failure Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

329

Study ID:

NCT03016325

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 105 Locations for this study

See Locations Near You

University of Arizona Sarver Heart Center
Tucson Arizona, 85724, United States
University of Florida
Gainesville Florida, 32610, United States
Tampa General Hospital
Tampa Florida, 33606, United States
Emory University
Atlanta Georgia, 30322, United States
Indiana University Health Methodist Hospital
Indianapolis Indiana, 46202, United States
University of Maryland Medical Center
Baltimore Maryland, 21201, United States
DMC Detroit Receiving Hospital
Detroit Michigan, 48201, United States
Harper University Hospital
Detroit Michigan, 48201, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Sinai Grace Hospital
Detroit Michigan, 48235, United States
Saint Louis University
Saint Louis Missouri, 63110, United States
Washington University
Saint Louis Missouri, 63110, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Wexner Medical Center at The Ohio State University
Columbus Ohio, 43210, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Medical University of South Carolina - PPDS
Charleston South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Ben Taub General Hospital
Houston Texas, 77030, United States
University of Utah Medical Center
Salt Lake City Utah, 84132, United States
University of Virginia Health System
Charlottesville Virginia, 22908, United States
Local Institution
Caba Buenos Aires, C1428, Argentina
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Rosario Santa FE, Santa, Argentina
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Buenos Aires , , Argentina
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Cordoba , 5000, Argentina
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Cordoba , X5000, Argentina
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Cordoba , X5000, Argentina
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Cordoba , X5000, Argentina
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Cordoba , , Argentina
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Corrientes , 3400, Argentina
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Santa Fe , 3000, Argentina
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Edmonton Alberta, T6G 2, Canada
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Halifax Nova Scotia, B3H 4, Canada
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Quebec , G1V 4, Canada
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Brno , 625 0, Czechia
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Brno , 656 9, Czechia
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Hradec Kralove , 500 0, Czechia
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Plzen-Bory , 305 9, Czechia
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Prague , 12808, Czechia
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Praha 4 , 140 2, Czechia
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Slany , 274 0, Czechia
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Besancon , 25000, France
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Beziers , 34500, France
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Bobigny , 93009, France
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Creteil , , France
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Evreux , 27015, France
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La Tronche , 38700, France
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Paris Cedex 10 , 75475, France
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Paris , 75013, France
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Bad Nauheim , 61231, Germany
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Frankfurt , 60590, Germany
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Gottingen , 37075, Germany
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Greifswald , , Germany
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Hamburg , 20246, Germany
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Hannover , 30625, Germany
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Homburg , 66421, Germany
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Ludwigshafen , 67063, Germany
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Mainz , , Germany
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Regensburg , 93505, Germany
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Athens, Attiki , 11527, Greece
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Athens , 11527, Greece
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Athens , 12464, Greece
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Athens , 14233, Greece
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Ioannina , 45500, Greece
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Kallithea , 17674, Greece
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Larisa , 41110, Greece
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Thessaloniki , 54636, Greece
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Brescia , 25123, Italy
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Ferrara , 44121, Italy
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Foggia , 71121, Italy
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Nagoya-shi Aichi, 46786, Japan
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Seto Aichi, 489-0, Japan
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Fukushima-shi Fukushima, 96012, Japan
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Sapporo-shi Hokkaido, 06086, Japan
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Amagasaki Hyogo, 66085, Japan
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Sagamihara-shi Kanagawa, 25203, Japan
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Yokohama Kanagawa, 227-8, Japan
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Yokohama Kanagawa, 232-0, Japan
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Okayama-shi Okayama, 70085, Japan
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Suita-shi Osaka, , Japan
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Kawaguchi Saitama, 333-0, Japan
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Bunkyo-ku Tokyo, 11384, Japan
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Bunkyo-ku Tokyo, 11386, Japan
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Itabashi-ku Tokyo, 17386, Japan
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Osaka , 558-8, Japan
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Tokyo , 113-8, Japan
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Tokyo , 162-8, Japan
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Amersfoort , 3818 , Netherlands
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Deventer , 7416 , Netherlands
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Hardenberg , 7772 , Netherlands
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Leeuwarden , 8934 , Netherlands
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Bialystok , 15-27, Poland
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Katowice , 40-63, Poland
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Krakow , 31-20, Poland
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Lodz , 91-34, Poland
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Lodz , 92-21, Poland
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Warszawa , 04-62, Poland
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Wroclaw , 50-98, Poland
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Wroclaw , 54-04, Poland
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Zamosc , 22-40, Poland
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Alicante , 03010, Spain
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Barcelona , 08025, Spain
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Barcelona , 8035, Spain
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L'Hospitalet de Llobregat , 08907, Spain
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Madrid , 28007, Spain
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Madrid , 28041, Spain
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Sant Joan Despi , 08970, Spain
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Santiago De Compostela , 15706, Spain
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Belfast , BT16 , United Kingdom
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Blackpool , FY3 8, United Kingdom
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Glasgow , G4 0S, United Kingdom
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Glasgow , G51 4, United Kingdom
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London , SW17 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

329

Study ID:

NCT03016325

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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