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Monoclonal Antibodies
BMS-986435 for Heart Failure (AURORA-HFpEF Trial)
Phase 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability
Be older than 18 years old
Must not have
Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy
Participants must not have a known diagnosis of infiltrative/storage disorder such as cardiac amyloidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial is testing a new drug called BMS-986435/MYK-224 in people with a specific type of heart failure (HFpEF). The goal is to see if the drug is safe and if it can help improve heart function and reduce symptoms.
Who is the study for?
This trial is for adults with stable, symptomatic heart failure but whose hearts can still pump normally (HFpEF). People with obstructive or genetic heart muscle issues, storage disorders like cardiac amyloidosis, or any serious condition that could affect the study or be risky can't join.
What is being tested?
The study tests BMS-986435/MYK-224's safety and how well it's tolerated in people with HFpEF. It also looks at how drug levels relate to its effects. Participants will either receive this new drug or a placebo for comparison.
What are the potential side effects?
While specific side effects of BMS-986435/MYK-224 are not listed here, common ones may include reactions at the injection site, nausea, fatigue, dizziness and potential impact on kidney function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stable heart failure with preserved ejection fraction.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a known heart condition involving thickened heart muscles.
Select...
I do not have a condition like cardiac amyloidosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BMS-986435Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986435
2024
Completed Phase 1
~20
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Heart Failure (HF) include ACE inhibitors, beta-blockers, diuretics, and mineralocorticoid receptor antagonists. ACE inhibitors reduce the production of angiotensin II, leading to vasodilation and decreased blood pressure.
Beta-blockers slow the heart rate and reduce myocardial oxygen demand. Diuretics help eliminate excess fluid, reducing the workload on the heart.
Mineralocorticoid receptor antagonists block the effects of aldosterone, decreasing fluid retention and fibrosis. For HFpEF, investigational agents like BMS-986435/MYK-224 are being studied to improve heart function and symptoms.
Understanding these mechanisms is crucial for HF patients as it helps tailor treatments to improve heart function, reduce symptoms, and enhance quality of life.
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,935 Total Patients Enrolled
28 Trials studying Heart Failure
169,253 Patients Enrolled for Heart Failure