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
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
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There are 105 Locations for this study
Tucson Arizona, 85724, United States
Gainesville Florida, 32610, United States
Tampa Florida, 33606, United States
Atlanta Georgia, 30322, United States
Indianapolis Indiana, 46202, United States
Baltimore Maryland, 21201, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Detroit Michigan, 48235, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45267, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Charleston South Carolina, 29425, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Charlottesville Virginia, 22908, United States
Caba Buenos Aires, C1428, Argentina
Rosario Santa FE, Santa, Argentina
Buenos Aires , , Argentina
Cordoba , 5000, Argentina
Cordoba , X5000, Argentina
Cordoba , X5000, Argentina
Cordoba , X5000, Argentina
Cordoba , , Argentina
Corrientes , 3400, Argentina
Santa Fe , 3000, Argentina
Edmonton Alberta, T6G 2, Canada
Halifax Nova Scotia, B3H 4, Canada
Quebec , G1V 4, Canada
Brno , 625 0, Czechia
Brno , 656 9, Czechia
Hradec Kralove , 500 0, Czechia
Plzen-Bory , 305 9, Czechia
Prague , 12808, Czechia
Praha 4 , 140 2, Czechia
Slany , 274 0, Czechia
Besancon , 25000, France
Beziers , 34500, France
Bobigny , 93009, France
Creteil , , France
Evreux , 27015, France
La Tronche , 38700, France
Paris Cedex 10 , 75475, France
Paris , 75013, France
Bad Nauheim , 61231, Germany
Frankfurt , 60590, Germany
Gottingen , 37075, Germany
Greifswald , , Germany
Hamburg , 20246, Germany
Hannover , 30625, Germany
Homburg , 66421, Germany
Ludwigshafen , 67063, Germany
Mainz , , Germany
Regensburg , 93505, Germany
Athens, Attiki , 11527, Greece
Athens , 11527, Greece
Athens , 12464, Greece
Athens , 14233, Greece
Ioannina , 45500, Greece
Kallithea , 17674, Greece
Larisa , 41110, Greece
Thessaloniki , 54636, Greece
Brescia , 25123, Italy
Ferrara , 44121, Italy
Foggia , 71121, Italy
Nagoya-shi Aichi, 46786, Japan
Seto Aichi, 489-0, Japan
Fukushima-shi Fukushima, 96012, Japan
Sapporo-shi Hokkaido, 06086, Japan
Amagasaki Hyogo, 66085, Japan
Sagamihara-shi Kanagawa, 25203, Japan
Yokohama Kanagawa, 227-8, Japan
Yokohama Kanagawa, 232-0, Japan
Okayama-shi Okayama, 70085, Japan
Suita-shi Osaka, , Japan
Kawaguchi Saitama, 333-0, Japan
Bunkyo-ku Tokyo, 11384, Japan
Bunkyo-ku Tokyo, 11386, Japan
Itabashi-ku Tokyo, 17386, Japan
Osaka , 558-8, Japan
Tokyo , 113-8, Japan
Tokyo , 162-8, Japan
Amersfoort , 3818 , Netherlands
Deventer , 7416 , Netherlands
Hardenberg , 7772 , Netherlands
Leeuwarden , 8934 , Netherlands
Bialystok , 15-27, Poland
Katowice , 40-63, Poland
Krakow , 31-20, Poland
Lodz , 91-34, Poland
Lodz , 92-21, Poland
Warszawa , 04-62, Poland
Wroclaw , 50-98, Poland
Wroclaw , 54-04, Poland
Zamosc , 22-40, Poland
Alicante , 03010, Spain
Barcelona , 08025, Spain
Barcelona , 8035, Spain
L'Hospitalet de Llobregat , 08907, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Sant Joan Despi , 08970, Spain
Santiago De Compostela , 15706, Spain
Belfast , BT16 , United Kingdom
Blackpool , FY3 8, United Kingdom
Glasgow , G4 0S, United Kingdom
Glasgow , G51 4, United Kingdom
London , SW17 , United Kingdom
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