RECRUITING

Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

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Conditions

Heart FailureBMS-986435MYK-224PharmacokineticsPharmacodynamicsSafetyHFpEF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).

Official Title

A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Quick Facts

Study Start:2023-11-07
Study Completion:2026-07-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06122779

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.

Ages Eligible for Study:40 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Infinite Clinical Research
Miami, Florida, 33133-4223
United States
Local Institution - 0014
Atlanta, Georgia, 30322-1013
United States
Local Institution - 0048
Atlanta, Georgia, 30322-1013
United States
Bluhm Cardiovascular Institute of Northwestern
Chicago, Illinois, 60611-5969
United States
Chicago Medical Research, LLC
Hazel Crest, Illinois, 60429-2196
United States
Ascension Medical Group St. Vincent - Indianapolis Heart Care
Indianapolis, Indiana, 46260-1992
United States
Local Institution - 0045
Indianapolis, Indiana, 46260-1992
United States
St. Louis Heart and Vascular
Saint Louis, Missouri, 63136-6111
United States
Local Institution - 0043
Saint Louis, Missouri, 63136
United States
Weill Cornell Medicine
New York, New York, 10065-4805
United States
Local Institution - 0041
Oklahoma City, Oklahoma, 73135-2607
United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135-2607
United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388-8260
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Angiocardiac Care of Texas - PA - PPDS
Houston, Texas, 77025-5253
United States
Local Institution - 0051
Houston, Texas, 77025-5253
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

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 Registration Dates

Study Start Date2023-11-07
Study Completion Date2026-07-03

Study Record Updates

Study Start Date2023-11-07
Study Completion Date2026-07-03

Terms related to this study

Keywords Provided by Researchers

  • BMS-986435
  • MYK-224
  • Pharmacokinetics
  • Pharmacodynamics
  • Safety
  • HFpEF

Additional Relevant MeSH Terms

  • Heart Failure