What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for heart failure include beta-blockers, ACE inhibitors, ARBs, diuretics, SGLT2 inhibitors, and neprilysin inhibitors. Beta-blockers can cause fatigue, bradycardia, and hypotension. ACE inhibitors and ARBs may lead to cough, hyperkalemia, and renal impairment. Diuretics often result in electrolyte imbalances and dehydration. SGLT2 inhibitors can cause urinary tract infections and genital infections. Neprilysin inhibitors, combined with ARBs, may cause hypotension, hyperkalemia, and renal dysfunction. These side effects should be monitored and managed by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of heart failure, including beta-blockers (e.g., carvedilol, metoprolol), ACE inhibitors (e.g., enalapril, lisinopril), angiotensin II receptor blockers (ARBs) (e.g., losartan, valsartan), and aldosterone antagonists (e.g., spironolactone, eplerenone). More recently, SGLT2 inhibitors like dapagliflozin and empagliflozin have been approved for heart failure with reduced ejection fraction (HFrEF) and are being studied for HFpEF. Additionally, sacubitril/valsartan, a combination of an ARB and a neprilysin inhibitor, has been approved for HFrEF. These treatments aim to improve symptoms, reduce hospitalizations, and increase survival in heart failure patients.

What other types of research exist?

Promising novel alternatives for Heart Failure patients in 2024 include: 1) Vericiguat, a soluble guanylate cyclase stimulator, which has shown benefits in reducing heart failure-related hospitalizations and cardiovascular death. 2) Omecamtiv mecarbil, a cardiac myosin activator, which improves cardiac contractility and has demonstrated positive outcomes in clinical trials. 3) SGLT2 inhibitors like dapagliflozin and empagliflozin, which have been shown to reduce the risk of heart failure hospitalization and cardiovascular death in patients with heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF).

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BMS-986435Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 3Eligibility criteria met

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.