Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure

Study Overview
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Brief Summary
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The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.

Official Title
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A Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of BMS-986259 in Stabilized Patients Hospitalized for Acute Decompensated Heart Failure

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Drug: BMS-986259
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986259<br> | Drug: BMS-986259<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing Clinically Relevant Hypotension | Clinically Relevant Hypotension is defined as occurrence of any of the following: Supine Systolic Blood Pressure (SBP) <85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension Supine SBP <90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension (eg, dizziness, lightheadedness, etc). | From first dose to 30 days following first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Serum Concentration (Cmax) |  | Day 1 and Day 5 of study treatment | 
| Time of Maximum Observed Serum Concentration (Tmax) |  | Day 1 and Day 5 of study treatment | 
| Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU)) |  | Day 1 and Day 5 of study treatment | 
| Trough Concentration (Ctrough) |  | Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure