What side effects are associated with this type of intervention?

Common treatments for heart failure include ACE inhibitors, beta-blockers, diuretics, and myosin inhibitors like Mavacamten. ACE inhibitors can cause cough, elevated blood potassium levels, and kidney dysfunction. Beta-blockers may lead to fatigue, cold extremities, and bradycardia. Diuretics often result in electrolyte imbalances and dehydration. Mavacamten, a myosin inhibitor, is being studied for its safety and tolerability, with potential side effects including reduced ejection fraction and heart failure symptoms. Patients should discuss these options and their side effects with their healthcare provider.

What prior FDA approvals exist?

Mavacamten is a myosin inhibitor currently being studied for heart failure with preserved ejection fraction (HFpEF). While specific FDA approvals for myosin inhibitors in heart failure are limited, other classes of drugs have been approved for heart failure treatment. These include ACE inhibitors (e.g., enalapril), beta-blockers (e.g., carvedilol), angiotensin II receptor blockers (e.g., losartan), and mineralocorticoid receptor antagonists (e.g., spironolactone). These medications work through various mechanisms to reduce the workload on the heart, manage blood pressure, and improve heart function.

What other types of research exist?

Promising novel alternatives to Mavacamten for heart failure patients in 2024 include: 1) SGLT2 inhibitors (e.g., empagliflozin, dapagliflozin) which have shown benefits in heart failure patients with preserved ejection fraction. 2) Vericiguat, a soluble guanylate cyclase stimulator, which has been approved for heart failure with reduced ejection fraction but is being studied for HFpEF. 3) Omecamtiv mecarbil, a cardiac myosin activator, which is being investigated for its potential benefits in heart failure patients. These alternatives offer different mechanisms of action and have shown promise in recent studies.

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Myosin Inhibitor

Mavacamten for Heart Failure (EMBARK-HFpEF Trial)

Phase 2

Waitlist Available

Research Sponsored by MyoKardia, Inc.

Eligibility Criteria Checklist

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

Must have

Body weight is greater than 45 kg at Screening

Is at least 50 years old at Screening

Must not have

Has severe chronic obstructive pulmonary disease, or other severe pulmonary disease, requiring specific treatments

Has known moderate or severe aortic valve stenosis, hemodynamically significant mitral stenosis, or severe mitral or tricuspid regurgitation at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called mavacamten to see if it can help people with a type of heart failure that doesn't respond well to usual treatments. The study focuses on patients with high levels of certain indicators in their blood. Mavacamten works by helping the heart muscle relax, making it easier for the heart to pump blood. Mavacamten is a new treatment for a heart condition and is the first disease-specific treatment for this condition.

Who is the study for?

This trial is for people over 50 with heart failure who have a body weight over 45 kg and documented evidence of heart failure. They must meet specific criteria related to NT-proBNP, LVEF, and NYHA class II or III symptoms. Those with certain heart conditions, severe lung disease, recent acute heart failure events, or extremely high BMI are excluded.

What is being tested?

The study tests the safety and effectiveness of mavacamten in patients with HFpEF who show elevated levels of NT-proBNP biomarkers. It's a Phase 2a trial designed to inform future studies on how mavacamten could help these patients.

What are the potential side effects?

While not explicitly listed here, potential side effects may include issues common to other heart medications such as dizziness, low blood pressure, changes in heartbeat rhythm or rate, fatigue, and possible worsening of the condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight is over 45 kg.

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe lung disease needing specific treatments.

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I have a serious heart valve problem.

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I have been revived from sudden cardiac arrest or my heart device has activated in the last 6 months.

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I have been diagnosed with a heart condition that causes thickening or buildup affecting heart function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mavacamten effect on NT-proBNP levels (at rest)

Mavacamten effect on cTnT levels (at rest)

Side effects data

From 2020 Phase 3 trial • 251 Patients • NCT03470545

21%

Dizziness

15%

Dyspnoea

12%

Headache

12%

Nasopharyngitis

Atrial Fibrillation

Cough

Back pain

Upper respiratory tract infection

Palpitations

Syncope

Fatigue

Gastroesophageal reflux disease

Arthralgia

Diarrhoea

Stress cardiomyopathy

Angina pectoris

Cardiac Failure

Cardiogenic shock

Pericardial effusion

Systolic dysfunction

Atrial septal defect

Abdominal Pain

Bacterial colitis

Diverticulitis

Infection

Contusion

Forearm Fracture

SLE

Ischaemic stroke

Device inappropriate shock delivery

100%

80%

60%

40%

20%

Study treatment Arm

Mavacamten (MYK-461)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: mavacamten (MYK-461)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mavacamten

2018

Completed Phase 3

~360

0 / 6Eligibility 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

Heart failure treatments often target the underlying mechanisms that impair heart function. Common treatments include ACE inhibitors and beta-blockers, which reduce the workload on the heart by lowering blood pressure and heart rate, respectively. Diuretics help remove excess fluid, reducing symptoms like swelling and shortness of breath. Myosin inhibitors, such as Mavacamten, work by reducing excessive cardiac muscle contraction, which can improve heart function and symptoms in patients with heart failure with preserved ejection fraction (HFpEF). These treatments are crucial as they address the specific pathophysiological changes in heart failure, improving quality of life and reducing hospitalizations.