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Completed

NCT Number: NCT04318093

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

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

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Key information

Conditions

Acute Decompensated Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0009, Ciudad de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986259

Drug

Specified dose on specified days

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Percentage of Participants Experiencing Clinically Relevant Hypotension

    Time frame: From first dose to 30 days following first dose

    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).

Secondary outcomes

  1. Maximum Observed Serum Concentration (Cmax)

    Time frame: Day 1 and Day 5 of study treatment

  2. Time of Maximum Observed Serum Concentration (Tmax)

    Time frame: Day 1 and Day 5 of study treatment

  3. Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))

    Time frame: Day 1 and Day 5 of study treatment

  4. Trough Concentration (Ctrough)

    Time frame: Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2020
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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