Phase 2
N=25
Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT04318093 ↗Enrolled (actual)
25
Serious AEs
28.0%
Results posted
Aug 2022
Primary outcome: Primary: Percentage of Participants Experiencing Clinically Relevant Hypotension — 15.4; 16.7 Percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS-986259 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Clinically Relevant Hypotension |
15.4; 16.7 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) |
105; 268 | — |
| SECONDARY Time of Maximum Observed Serum Concentration (Tmax) |
11.0; 7.97 | — |
| SECONDARY Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU)) |
1778; 5156 | — |
| SECONDARY Trough Concentration (Ctrough) |
79.9; 145; 181; 185; 210; 260 | — |
Summary
The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Participants currently hospitalized for acute decompensated heart failure (ADHF)
- Participants must be hemodynamically stable, as assessed by the investigator
- Men must agree to follow specific methods of contraception, if applicable, while participating in the trial
- Women participants must have documented proof that they are not of childbearing potential
Exclusion Criteria
- Acute cardiovascular condition other than heart failure (HF) decompensation
- Cardiogenic shock at presentation to emergency room (ER) or at any time before randomization
- Recipient of ventricular assist devices or use of any cardiac extracorporeal devices, within 12 weeks of study randomization
- Participants with contraindications to vasodilator therapy such as restrictive or obstructive cardiomyopathy, severe mitral or aortic stenosis
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT04318093). 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.