Study of the safety of BMS-986259 in participants with post-acute decompensated heart failure

Phase 1

• Conditions: Heart failure; MedDRA version: 20.0Level: HLGTClassification code 10019280Term: Heart failuresSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-004186-40-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-27
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

-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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified