Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure
NCT ID: NCT03016325
Last Updated: 2021-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
329 participants
INTERVENTIONAL
2017-01-13
2019-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1 Cohort 1 HNO Donor
HNO Donor
Infusion
Placebo Part 1 Cohort 1
Placebo
Infusion
Part 2 Cohort 2 HNO Donor- low dose
HNO Donor
Infusion
Part 2 Cohort 2 HNO Donor- high dose
HNO Donor
Infusion
Placebo Part 2 Cohort 2
Placebo
Infusion
Interventions
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HNO Donor
Infusion
Placebo
Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University of Arizona Sarver Heart Center
Tucson, Arizona, United States
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
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, , Argentina
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Corrientes, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Santa Fe, , Argentina
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Québec, Quebec, Canada
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Brno, , Czechia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Plzen-Bory, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Slaný, , Czechia
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Besançon, , France
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Béziers, , France
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Bobigny, , France
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Créteil, , France
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Évreux, , France
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La Tronche, , France
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Paris, , France
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Paris, , France
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Bad Nauheim, , Germany
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Frankfurt, , Germany
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Göttingen, , Germany
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Greifswald, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Homburg, , Germany
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Ludwigshafen, , Germany
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Mainz, , Germany
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Regensburg, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, Attiki, , Greece
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Ioannina, , Greece
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Kallithea, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Brescia, , Italy
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Ferrara, , Italy
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Foggia, , Italy
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Nagoya, Aichi-ken, Japan
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Seto, Aichi-ken, Japan
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Fukushima, Fukushima, Japan
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Sapporo, Hokkaido, Japan
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Amagasaki, Hyōgo, Japan
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Sagamihara-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Okayama, Okayama-ken, Japan
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Suita-shi, Osaka, Japan
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Kawaguchi, Saitama, Japan
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Bunkyo-ku, Tokyo, Japan
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Bunkyo-ku, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Osaka, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Amersfoort, , Netherlands
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Deventer, , Netherlands
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Hardenberg, , Netherlands
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Leeuwarden, , Netherlands
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Bialystok, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Zamość, , Poland
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Alicante, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Sant Joan Despí, , Spain
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Santiago de Compostela, , Spain
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Belfast, , United Kingdom
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Blackpool, , United Kingdom
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Glasgow, , United Kingdom
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Glasgow, , United Kingdom
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London, , United Kingdom
Countries
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References
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Felker GM, McMurray JJV, Cleland JG, O'Connor CM, Teerlink JR, Voors AA, Belohlavek J, Bohm M, Borentain M, Bueno H, Cole RT, DeSouza MM, Ezekowitz JA, Filippatos G, Lang NN, Kessler PD, Martinez FA, Mebazaa A, Metra M, Mosterd A, Pang PS, Ponikowski P, Sato N, Seiffert D, Ye J. Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study. JACC Heart Fail. 2021 Feb;9(2):146-157. doi: 10.1016/j.jchf.2020.10.012. Epub 2020 Nov 25.
Cowart D, Venuti RP, Lynch K, Guptill JT, Noveck RJ, Foo SY. A Phase 1 Randomized Study of Single Intravenous Infusions of the Novel Nitroxyl Donor BMS-986231 in Healthy Volunteers. J Clin Pharmacol. 2019 May;59(5):717-730. doi: 10.1002/jcph.1364. Epub 2019 Jan 31.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2016-001685-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV013-011
Identifier Type: -
Identifier Source: org_study_id
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