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

August 3, 2022 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5006
        • Local Institution - 0025
    • Buenos Aires
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, 1180
        • Local Institution - 0009
    • Cordoba
      • Alberdi, Cordoba, Argentina, 5000
        • Local Institution - 0007
      • Córdoba, Cordoba, Argentina, X5000EPU
        • Local Institution - 0010
    • Distrito Federal
      • Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1093AAS
        • Local Institution
    • Provincia DE Cordoba
      • Cordoba, Provincia DE Cordoba, Argentina, 5000
        • Local Institution - 0028
  • Czechia
      • Praha 2, Czechia, 12808
        • Local Institution - 0020
      • Slany, Czechia, 274 01
        • Nemocnice Slany-Interna - kardiologicka ambulance
  • Greece
      • Athens, Greece, 11527
        • Local Institution - 0011
      • Athens, Greece, 142 33
        • Local Institution - 0022
  • Israel
      • Jerusalem, Israel, 912001
        • Local Institution
      • Petah Tikva, Israel, 4941492
        • Local Institution
    • Tell Abīb
      • Tel Aviv, Tell Abīb, Israel, 6423906
        • Local Institution - 0014
  • Poland
      • Bialystok, Poland, 15 276
        • Local Institution - 0034
      • Wrocaw, Poland, 50-556
        • Local Institution - 0030
      • Wroclaw, Poland, 54-049
        • Local Institution - 0027
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Local Institution
      • Swindon, United Kingdom, SN3 6BB
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From first dose to 30 days following first dose

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2020

Primary Completion (Actual)

July 19, 2021

Study Completion (Actual)

July 19, 2021

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV019-010
  • 2019-004186-40 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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