Study of the safety of BMS-986259 in participants with post-acute decompensated heart failure
- Conditions
- Heart failureMedDRA version: 20.0Level: HLGTClassification code 10019280Term: Heart failuresSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-004186-40-NL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 72
-Patients currently hospitalized for acute decompensated heart failure (ADHF)
-Patients 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish safety & tolerability of BMS-986259 when initiated inhospital in stabilized participants post-ADHF.;Timepoint(s) of evaluation of this end point: Up to 14 days;Secondary Objective: To evaluate serum PK parameters in participants with HF<br>;Primary end point(s): Incidence of clinically relevant hypotension, defined as:<br>- Supine SBP =< 85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension<br>OR<br>- Supine SBP =< 90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension
- Secondary Outcome Measures
Name Time Method