A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
NCT ID: NCT03357731
Last Updated: 2020-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2017-11-30
2019-05-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Placebo/BMS-986231/NTG
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
HNO Donor
Infusion
Nitroglycerin (NTG)
Infusion
Placebo
Infusion
Placebo/NTG/BMS-986231
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
HNO Donor
Infusion
Nitroglycerin (NTG)
Infusion
Placebo
Infusion
NTG/Placebo/BMS-986231
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
HNO Donor
Infusion
Nitroglycerin (NTG)
Infusion
Placebo
Infusion
NTG/BMS-986231/Placebo
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
HNO Donor
Infusion
Nitroglycerin (NTG)
Infusion
Placebo
Infusion
BMS-986231/Placebo/NTG
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
HNO Donor
Infusion
Nitroglycerin (NTG)
Infusion
Placebo
Infusion
BMS-986231/NTG/Placebo
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
HNO Donor
Infusion
Nitroglycerin (NTG)
Infusion
Placebo
Infusion
Interventions
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HNO Donor
Infusion
Nitroglycerin (NTG)
Infusion
Placebo
Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable guideline directed therapy for heart failure including oral diuretics, ACEi, ARBs, ARNi, MRAs, and β blockers as tolerated, with no dose changes of these medications in the past 2 weeks
* Have screening values of NT pro-BNP ≥ 125 pg/mL (15 pmol/L) or BNP ≥ 35 pg/mL (10 pmol/L)
Exclusion Criteria
* Heart rate \< 50 beats per minute (bpm) or \> 90 bpm at screening or pre-randomization
* Permanent Atrial Fibrillation, Atrial Flutter or having Atrial Fibrillation, Atrial Flutter
* Estimated glomerular filtration rate (eGFR) \< 15 ml/min/1.73 m2
* Ventricular assist device or prior heart transplant
* Prior solid organ transplant
* Body weight \< 45 kg or ≥ 140 kg
* Low quality echocardiographic visualization windows and image acquisition
* Permanent paced rhythm (VVI, DDD or BiV pacing)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Locations
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Orange County Research Center
Tustin, California, United States
Northwestern Medicine
Chicago, Illinois, United States
Indiana University School of Medicine-Indianapolis
Indianapolis, Indiana, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Duke Advanced Heart and Lung Failure Clinic
Durham, North Carolina, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, United States
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Kawasaki, Kanagawa, Japan
Local Institution
Suita-shi, Osaka, Japan
Local Institution
Groiningen, , Netherlands
Local Institution
Edinburgh, , United Kingdom
Local Institution
Glasgow, , United Kingdom
Local Institution
Glasgow, , United Kingdom
Local Institution
Glasgow, , United Kingdom
Local Institution
Harrow, , United Kingdom
Local Institution
London, , United Kingdom
Local Institution
London, , United Kingdom
Local Institution
London, , United Kingdom
Countries
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References
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Felker GM, Borentain M, Cleland JG, DeSouza MM, Kessler PD, O'Connor CM, Seiffert D, Teerlink JR, Voors AA, McMurray JJV. Rationale and design for the development of a novel nitroxyl donor in patients with acute heart failure. Eur J Heart Fail. 2019 Aug;21(8):1022-1031. doi: 10.1002/ejhf.1504. Epub 2019 Jun 6.
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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2016-003586-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV013-020
Identifier Type: -
Identifier Source: org_study_id
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