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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 22 days, optional extension of up to 96 weeks
Awards & highlights

Study Summary

This trial will test if danicamtiv is safe and effective in treating primary dilated cardiomyopathy caused by MYH7 or TTN variants.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 22 days, optional extension of up to 96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 22 days, optional extension of up to 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and severity of treatment-emergent adverse events and serious adverse events.
Number of participants with ECG abnormalities
Number of participants with adverse event abnormalities
+3 more
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

MyoKardia, Inc.Lead Sponsor
12 Previous Clinical Trials
1,012 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,642 Previous Clinical Trials
4,130,083 Total Patients Enrolled

Media Library

danicamtiv (Cardiac Myosin Activator) Clinical Trial Eligibility Overview. Trial Name: NCT04572893 — Phase 2
Dilated Cardiomyopathy Research Study Groups: MYK-491
Dilated Cardiomyopathy Clinical Trial 2023: danicamtiv Highlights & Side Effects. Trial Name: NCT04572893 — Phase 2
danicamtiv (Cardiac Myosin Activator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04572893 — Phase 2
Dilated Cardiomyopathy Patient Testimony for trial: Trial Name: NCT04572893 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is this medical experiment being populated?

"Affirmative. Clinicaltrials.gov conveys that this medical investigation, first published on August 4th 2020, is actively searching for candidates. Approximately 24 individuals must be recruited from 21 different clinical trial sites."

Answered by AI

To what extent is danicamtiv a risk to individuals?

"Despite being a Phase 2 trial and lacking data supporting efficacy, our team at Power rated the safety of danicamtiv as a 2 due to existing evidence indicating its security."

Answered by AI

Is enrollment for this medical experiment open to seniors aged 75 and older?

"This clinical trial is seeking participants aged 18 and above, but below 80 years old."

Answered by AI

What kind of individuals would be amenable to involvement in this experiment?

"To be eligible for the trial, individuals must have primary familial dilated cardiomyopathy and fall within a specific age range (18-80). Currently, there are 24 participants being recruited."

Answered by AI

Are there numerous venues that are currently hosting this clinical trial within the US?

"Currently, 21 medical centres across the United States are accepting participants for this trial. From Tampa to Austin and Boston; there is a clinic nearby that could help you limit travel time should you choose to participate."

Answered by AI

Is there any availability for individuals to join this experimental research?

"Affirmative. The clinicaltrials.gov website attests to this trial's active recruitment of participants, which commenced on August 4th 2020 and was last updated June 15th 2022. The study is seeking 24 people from 21 distinct medical facilities."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
MedStar Georgetown University Hospital
University of Pennsylvania - Heart and Vascular Center
Austin Heart
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I am interested in exploring new medical treatments. I would be interested in trying alternate medications and treatments.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How often are you seen by a doctor during this trial?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities
2020. "Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04572893.
~9 spots leftby May 2025
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