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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 15 weeks

Awards & highlights

AURORA-HFpEF Trial Summary

This trial will study a drug to see if it's safe & effective in treating heart failure with preserved ejection fraction.

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.Check my eligibility

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.See study design

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.

AURORA-HFpEF Trial 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.

AURORA-HFpEF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of AEs leading to treatment discontinuation

Incidence of serious adverse events (SAEs)

Incidence of treatment emergent adverse events (TEAEs)

Secondary outcome measures

Summary of plasma concentrations of MYK-224

AURORA-HFpEF Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BMS-986435Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 1Eligibility 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.

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Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,650 Previous Clinical Trials

4,130,784 Total Patients Enrolled

28 Trials studying Heart Failure

169,228 Patients Enrolled for Heart Failure

~24 spots leftby Jan 2025

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