What side effects are associated with this type of intervention?

The most common treatments for Hypertrophic Cardiomyopathy (HCM) include beta-blockers, calcium channel blockers, and cardiac myosin inhibitors like Mavacamten. Beta-blockers can cause side effects such as fatigue, dizziness, and bradycardia. Calcium channel blockers may lead to symptoms like headache, peripheral edema, and constipation. Mavacamten, a cardiac myosin inhibitor, is being studied for its safety and efficacy; known side effects from similar treatments include potential heart failure, arrhythmias, and hypotension. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for Hypertrophic Cardiomyopathy (HCM), though specific approvals for cardiac myosin inhibitors like Mavacamten are relatively recent. Historically, treatments have included beta-blockers, calcium channel blockers, and antiarrhythmic drugs to manage symptoms and improve heart function. Mavacamten, a novel cardiac myosin inhibitor, represents a newer class of treatment aimed at directly targeting the underlying pathophysiology of HCM by reducing excessive contractility and improving cardiac relaxation.

What other types of research exist?

Promising alternatives to Mavacamten for Hypertrophic Cardiomyopathy patients include: 1) Aficamten, another cardiac myosin inhibitor currently in clinical trials. 2) Gene therapy approaches targeting the underlying genetic mutations causing HCM. 3) Emerging pharmacological agents such as L-type calcium channel blockers and late sodium current inhibitors, which are being investigated for their potential benefits in HCM management.

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Myosin Inhibitor

Mavacamten for Hypertrophic Cardiomyopathy (ODYSSEY-HCM Trial)

Phase 3

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called mavacamten to see if it is safe and effective for people with a heart condition that makes their heart muscle too thick. The goal is to help their heart work better and improve their symptoms.

Who is the study for?

This trial is for people with a heart condition called non-obstructive hypertrophic cardiomyopathy (nHCM). Participants should have significant thickening of the heart muscle, experience symptoms, and fall under specific classifications of heart function. They can't join if they've had unexplained fainting or dangerous irregular heartbeats recently, or if their condition might be due to another disease.

What is being tested?

The study is testing Mavacamten against a placebo to see if it's safe and effective for nHCM. Patients will randomly receive either the actual medication or a placebo without knowing which one they are taking.

What are the potential side effects?

While not specified here, common side effects from drugs like Mavacamten may include dizziness, headache, gastrointestinal discomfort, and potential changes in blood pressure or heart rhythm.

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

Side effects data

From 2024 Phase 3 trial • 112 Patients • NCT04349072

Fatigue

Dizziness

Headache

Dyspnoea

Palpitations

Dyspnoea exertional

Hypertension

Arthralgia

Atrial fibrillation

Peripheral venous disease

Cardiac failure congestive

Acute respiratory failure

Gastrooesophageal reflux disease

Sudden cardiac death

Fall

Large intestine perforation

Pneumatosis intestinalis

Nephrolithiasis

Pulmonary embolism

COVID-19

Clostridium difficile infection

100%

80%

60%

40%

20%

Study treatment Arm

Mavacamten

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MavacamtenExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mavacamten

2022

Completed Phase 3

~530

Do I qualify?Apply below to find out

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

Hypertrophic Cardiomyopathy (HCM) treatments aim to reduce symptoms and prevent complications by targeting the underlying mechanisms of the disease. Cardiac myosin inhibitors like Mavacamten work by reducing the hypercontractility of the heart muscle, thereby decreasing left ventricular outflow tract obstruction and improving cardiac function. Beta-blockers and calcium channel blockers help by slowing the heart rate and reducing myocardial contractility, which alleviates symptoms such as chest pain and shortness of breath. Septal reduction therapies, including surgical myectomy and alcohol septal ablation, physically reduce the thickened heart muscle to improve blood flow. These treatments are crucial for HCM patients as they help manage symptoms, improve quality of life, and reduce the risk of severe complications such as heart failure and sudden cardiac death.