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The trial is taking place at:
S

South Oklahoma Heart Research, LLC | Oklahoma City, OK

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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 2

Conditions

Heart Failure

Treatments

Other: Placebo
Drug: BMS-986435

Study type

Interventional

Funder types

Industry

Identifiers

NCT06122779
CV029-1001
2023-505919-21 (EudraCT Number)
U1111-1292-8451 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

48 estimated patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.

Exclusion Criteria

  • Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

48 participants in 2 patient groups, including a placebo group

BMS-986435
Experimental group
Treatment:
Drug: BMS-986435
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

51

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Central trial contact

First line of the email MUST contain NCT # and Site #.; BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Data sourced from clinicaltrials.gov

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