Status:
COMPLETED
Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
November 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04318093
Start Date
November 6 2020
End Date
July 19 2021
Last Update
August 4 2022
Active Locations (18)
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1
Local Institution - 0009
Ciudad de Buenos Aires, Buenos Aires, Argentina, 1180
2
Local Institution - 0007
Alberdi, Córdoba Province, Argentina, 5000
3
Local Institution - 0028
Córdoba, Córdoba Province, Argentina, 5000
4
Local Institution - 0010
Córdoba, Córdoba Province, Argentina, X5000EPU