What side effects are associated with this type of intervention?

Danicamtiv, a myosin activator, is being studied for its safety and efficacy in treating Dilated Cardiomyopathy (DCM). While specific side effects of Danicamtiv are not detailed, common treatments for DCM include beta-blockers, ACE inhibitors, and diuretics. Beta-blockers can cause fatigue, cold extremities, and bradycardia. ACE inhibitors may lead to cough, elevated blood potassium levels, and kidney dysfunction. Diuretics often result in electrolyte imbalances and dehydration. Patients should discuss potential side effects with their healthcare provider to tailor the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Dilated Cardiomyopathy (DCM), primarily focusing on managing symptoms and improving heart function. These include beta-blockers (e.g., carvedilol, metoprolol), ACE inhibitors (e.g., enalapril, lisinopril), and angiotensin II receptor blockers (e.g., losartan, valsartan). Additionally, aldosterone antagonists (e.g., spironolactone) and certain diuretics are used to manage fluid retention. While specific myosin activators like Danicamtiv are still under investigation, these existing treatments aim to reduce the workload on the heart and improve overall cardiac function.

What other types of research exist?

Promising novel alternatives to Danicamtiv for Dilated Cardiomyopathy patients include gene therapy approaches targeting specific genetic mutations (e.g., MYH7, TTN), and other myosin modulators currently in clinical trials. Additionally, therapies such as CRISPR-based gene editing and RNA-based treatments (e.g., antisense oligonucleotides) are being explored for their potential to address the underlying genetic causes of DCM.

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Cardiac Myosin Activator

Danicamtiv for Dilated Cardiomyopathy

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

For MYH7 and TTN cohorts, must have diagnosis of primary DCM (dilated cardiomyopathy), clinically stable and due to probably disease-causing variant of MYH7 or TTN

For the cohort of primary DCM due to causalities other than MYH7 and TTN, participant must have diagnosis of primary DCM with a cause not related to MYH7 or TTN variants

Must not have

Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, afterload reduction, or diuretics)

Presence of significant structural cardiac abnormalities including valvar dysfunction on Screening transthoracic echo(s)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 96 weeks

Awards & highlights

Summary

This trial is testing danicamtiv, a medication that may help people with a specific type of heart disease called dilated cardiomyopathy (DCM). It aims to see if the drug can make the heart pump blood more effectively in patients with certain genetic conditions.

Who is the study for?

This trial is for people with primary dilated cardiomyopathy (DCM) linked to MYH7 or TTN gene variants, or other causes. Participants must be clinically stable and have a clear diagnosis. They need good echocardiography imaging windows and no more than three family members can join the study. Those with significant heart structure issues, recent heart-related hospitalizations, or routine IV treatments for heart failure are excluded.

What is being tested?

The trial is testing danicamtiv's safety and early effectiveness in treating DCM due to specific genetic mutations or other reasons. It's a Phase 2a study which means it’s an early stage of testing where researchers look at how well the drug works and monitor its safety in a small group of patients.

What are the potential side effects?

While specific side effects for danicamtiv aren't listed here, common side effects from drugs treating DCM may include low blood pressure, kidney problems, electrolyte imbalances like low potassium or magnesium levels, fatigue, and potential worsening of the condition.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have stable dilated cardiomyopathy due to MYH7 or TTN gene changes.

Select...

My heart condition is not caused by MYH7 or TTN gene changes.

Exclusion Criteria

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

Select...

I receive regular IV treatments for heart failure.

Select...

I have heart valve problems detected on an echo test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 weeks for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change in pharmacodynamic (PD) parameters assessed by transthoracic echocardiography (TTE)

Trial Design

1Treatment groups

Experimental Treatment

Group I: MYK-491Experimental Treatment1 Intervention

Primary DCM due to MYH7 or TTN Variant or due to other causalities not related to MYH7 or TTN variants

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

Myosin activators like Danicamtiv enhance the contractility of the heart muscle by directly activating myosin, improving the heart's pumping efficiency without increasing intracellular calcium levels, thus reducing the risk of arrhythmias. This is crucial for Dilated Cardiomyopathy (DCM) patients, whose hearts struggle to pump effectively. Other common treatments include beta-blockers, which reduce the heart's workload and prevent arrhythmias, and ACE inhibitors or ARBs, which relax blood vessels and reduce strain on the heart. These treatments aim to improve heart function, alleviate symptoms, and prevent disease progression.

Direct Myosin Activation by Omecamtiv Mecarbil for Heart Failure with Reduced Ejection Fraction.