An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic
NCT ID: NCT03730961
Last Updated: 2021-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2019-01-17
2020-01-09
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
QUADRUPLE
Study Groups
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Placebo+Diuretic to BMS-986231+Diuretic
Administered in a cross over design with 8-hour continuous infusions and 7-28 day wash-out periods
BMS-986231
Intravenous administration
Furosemide
Intravenous administration
Placebo
Intravenous administration
BMS-986231+Diuretic to Placebo+Diuretic
Administered in a cross over design with 8-hour continuous infusions and 7-28 day wash-out periods
BMS-986231
Intravenous administration
Furosemide
Intravenous administration
Placebo
Intravenous administration
Interventions
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BMS-986231
Intravenous administration
Furosemide
Intravenous administration
Placebo
Intravenous administration
Eligibility Criteria
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Inclusion Criteria
* On stable chronic guideline-directed therapy for HF including chronic loop diuretics, ACEi, ARBs, MRAs, ARNI or / and β-blockers as tolerated, with no changes of these medications in the past 2 weeks
* At least an oral dose of 40 mg of furosemide/day or equivalent (20 mg torsemide, 1 mg bumetamide)
Exclusion Criteria
* Heart rate \< 50 beats per minute (bpm) or \> 120 bpm at screening or pre-randomization
* Primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic or uncorrected severe valvular disease
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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Glasgow Clinical Research Facility
Glasgow, , United Kingdom
Richmond Pharmacology
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: Study Protocol
Document Type: Statistical Analysis Plan
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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2018-000970-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV013-034
Identifier Type: -
Identifier Source: org_study_id
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