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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
No Placebo-Only Group
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 belowSelect...
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
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)
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: MYK-491Experimental Treatment1 Intervention
Primary DCM due to MYH7 or TTN Variant or due to other causalities not related to MYH7 or TTN variants
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.
Direct Myosin Activation by Omecamtiv Mecarbil for Heart Failure with Reduced Ejection Fraction.
Find a Location
Who is running the clinical trial?
MyoKardia, Inc.Lead Sponsor
12 Previous Clinical Trials
1,007 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,099,030 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart can be clearly seen on an ultrasound.I was hospitalized for heart failure in the last 3 months.I have stable dilated cardiomyopathy due to MYH7 or TTN gene changes.No more than 3 of my family members with the same genetic condition are in this study.I receive regular IV treatments for heart failure.My heart condition is not caused by MYH7 or TTN gene changes.I have heart valve problems detected on an echo test.You have certain abnormal test results when you first get screened for the study.I have had a heart attack or chest pain in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: MYK-491
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cardiomyopathy Patient Testimony for trial: Trial Name: NCT04572893 — Phase 2