An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Partic⦠(NCT03730961) | Clinical Trial Compass
CompletedPhase 2
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
United Kingdom23 participantsStarted 2019-01-17
Plain-language summary
The purpose of this study is to investigate continuous 8-hour introductions of BMS-986231 in participants with heart failure and weakened heart function given a standard dose of diuretic.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Left ventricular ejection fraction \<45%, as assessed by echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI) scan within 18 months
* 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:
* SBP \< 115 mm Hg or \> 180 mm Hg at screening or pre-randomization
* 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
Other protocol defined inclusion/exclusion criteria could apply
What they're measuring
1
4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo