Phase 2
Completed N=23
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
Cardiac Failure · Myocardial Failure · Heart Failure · Heart Decompensation
Source: ClinicalTrials.gov NCT03730961 ↗
Enrolled (actual)
23
Serious AEs
6.5%
Results posted
Jan 2021
Primary outcomePrimary: 4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo — 900.7; 1603.3; 1176.7; 1345.4 mL — p=0.0021
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo |
900.7; 1603.3; 1176.7; 1345.4; 1032.1; 1480.5 | 0.0021 sig |
| SECONDARY FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo |
0.5; 0.6; 0.6; 0.7; 4.6; 5.4 | 0.0163 sig |
| SECONDARY FeK in Participants With HFrEF While on BMS-986231 Compared to Placebo |
0.4; 0.4; 0.5; 0.4; 1.1; 0.9 | 0.1621 |
| SECONDARY Furosemide Urinary Concentrations |
0.2; 0.2; 0.1; 0.1; 0.3; 0.1 | — |
| SECONDARY Furosemide Plasma Concentrations |
1605; 63.6; 2049; 2145; 1122; 1146 | — |
| SECONDARY Ratio Urinary Sodium (Na) to Urinary Furosemide at 8 Hours Post-start Infusion |
6.1; 10.1 | — |
| SECONDARY Number of Participants With Clinically Relevant Hypotension |
4; 0 | — |
| SECONDARY Number of Participants With an Adverse Event (AE) |
8; 6 | — |
| SECONDARY Number of Participants With an Abnormal Clinical Laboratory Value |
0; 0 | — |
| SECONDARY Change From Baseline in Vital Signs - Blood Pressure |
-14.5; -0.6; -28.4; -4.9 | — |
| SECONDARY Change From Baseline in Vital Signs - Heart Rate |
0.5; -0.1 | — |
| SECONDARY Change From Baseline in Vital Signs - Oxygen Saturation |
-1.0; 0.0 | — |
| SECONDARY Change From Baseline in Electrocardiograms (ECGs) - Mean Heart Rate |
0.9; 1.6 | — |
| SECONDARY Change From Baseline in Electrocardiograms (ECGs) - PR, QRS Duration, QT, QTcF Intervals |
2.0; -2.8; -0.9; 2.2; -9.1; -7.9 | — |
| SECONDARY Telemetry |
— | — |
| SECONDARY Change From Baseline in Physical Examination - Body Weight |
0.2; -0.5 | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Left ventricular ejection fraction 180 mm Hg at screening or pre-randomization
- Heart rate 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
Data sourced from ClinicalTrials.gov (NCT03730961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.