What side effects are associated with this type of intervention?

Cardiac myosin inhibitors, such as Aficamten, used in the treatment of Hypertrophic Cardiomyopathy, can cause side effects including symptoms of heart failure (shortness of breath, fatigue, edema), arrhythmias, hypotension, and dizziness. Close monitoring by healthcare providers is essential to manage these risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Hypertrophic Cardiomyopathy (HCM), focusing on managing symptoms and improving heart function. Aficamten, a cardiac myosin inhibitor, is currently being studied for its long-term safety and tolerability in adults with HCM. Similar treatments include mavacamten, another cardiac myosin inhibitor, which has shown promise in reducing left ventricular outflow tract obstruction and improving symptoms in HCM patients. These drugs work by modulating the contractile function of the heart muscle, offering a targeted approach to managing HCM.

What other types of research exist?

Promising novel alternatives to Aficamten for Hypertrophic Cardiomyopathy patients include: 1. Mavacamten: Another cardiac myosin inhibitor that has shown efficacy in reducing left ventricular outflow tract obstruction and improving symptoms in HCM patients. 2. Gene therapy approaches: These are being explored to target the underlying genetic mutations causing HCM, potentially offering a more permanent solution. 3. CRISPR-based therapies: Emerging as a potential option to correct genetic mutations at the DNA level, though still in early stages of research. Patients should discuss these options with their healthcare provider to determine the best course of action based on their specific condition and treatment goals.

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Long-term Safety of Aficamten for Hypertrophic Cardiomyopathy (FOREST-HCM Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for Hypertrophic Cardiomyopathy (HCM) include beta-blockers, calcium channel blockers, and cardiac myosin inhibitors like Aficamten. Beta-blockers work by reducing heart rate and myocardial contractility, which decreases the oxygen demand of the heart. Calcium channel blockers help to relax the heart muscle and improve diastolic function. Cardiac myosin inhibitors, such as Aficamten, specifically target the myosin-actin cross-bridge formation, reducing hypercontractility and improving cardiac relaxation. These mechanisms are crucial for HCM patients as they help to alleviate symptoms, reduce the risk of arrhythmias, and improve overall cardiac function by addressing the underlying hypercontractility and impaired relaxation of the heart muscle.

Phase 2 & 3

Waitlist Available

Research Sponsored by Cytokinetics

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) since the completion of a prior trial of CK-3773274

Has participated in another investigational device or drug study or received an investigational device or drug < 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of study, up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is focused on collecting data about the safety and tolerability of a new medication called aficamten. The study involves people who are using this medication to see if it remains safe and well-tolerated over an extended period.

Who is the study for?

This trial is for individuals who have completed a previous Cytokinetics study with CK-3773274 and have a left ventricular ejection fraction (LVEF) of 55% or higher. It's not open to those who've had certain heart treatments, recent atrial fibrillation, or an investigational drug/device within the last month.

What is being tested?

The trial is focused on gathering long-term safety data for Aficamten (CK-3773274), which will be administered in doses ranging from 5 to 20 mg. This is an open-label study where all participants receive the drug.

What are the potential side effects?

While specific side effects are not listed here, this study aims to monitor any adverse reactions over a prolonged period as patients take Aficamten at varying dosages.

Eligibility Criteria

Exclusion Criteria

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

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I've had heart surgery or a procedure to reduce heart muscle thickness after my last CK-3773274 trial.

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I have not been part of any drug or device trials in the last month or longer, depending on the drug.

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I took mavacamten recently and haven't gotten approval from a medical expert to join.

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My heart's pumping ability was low (<40% LVEF) due to a medication in a previous study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of study, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to end of study, up to 5 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events observed during dosing of aficamten in patients with HCM

Secondary study objectives

Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of aficamten in patients with HCM

Incidence of serious adverse events observed during dosing of aficamten in patients with HCM

Long-term effects of aficamten on left ventricular outflow tract gradient (LVOT G) in patients with oHCM

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: Aficamten up to 20 mgExperimental Treatment1 Intervention

Patients in this arm take daily dose of aficamten. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.

0 / 4Eligibility 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

The most common treatments for Hypertrophic Cardiomyopathy (HCM) include beta-blockers, calcium channel blockers, and cardiac myosin inhibitors like Aficamten. Beta-blockers work by reducing heart rate and myocardial contractility, which decreases the oxygen demand of the heart. Calcium channel blockers help to relax the heart muscle and improve diastolic function. Cardiac myosin inhibitors, such as Aficamten, specifically target the myosin-actin cross-bridge formation, reducing hypercontractility and improving cardiac relaxation. These mechanisms are crucial for HCM patients as they help to alleviate symptoms, reduce the risk of arrhythmias, and improve overall cardiac function by addressing the underlying hypercontractility and impaired relaxation of the heart muscle.