Danicamtiv for Dilated Cardiomyopathy

Recruiting at 52 trial locations

Overseen By First line of the email MUST contain NCT # and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MyoKardia, Inc.

Must not be taking: Inotropes, Afterload reducers, Diuretics

Disqualifiers: Structural cardiac abnormalities, Recent coronary syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 96 weeks

41 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are receiving regular outpatient IV infusions for heart failure, you may not be eligible to participate.

How does the drug danicamtiv differ from other treatments for dilated cardiomyopathy?

Danicamtiv is unique because it is a heart myosin activator, which means it works by directly increasing the heart's ability to contract, unlike other treatments that primarily focus on managing symptoms or slowing disease progression. ^{1 2 3 4 5}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

My heart can be clearly seen on an ultrasound.

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.

Exclusion Criteria

I was hospitalized for heart failure in the last 3 months.

I receive regular IV treatments for heart failure.

I have heart valve problems detected on an echo test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive danicamtiv to assess safety and preliminary efficacy in treating primary dilated cardiomyopathy

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• danicamtiv

Trial Overview 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.

Participant Groups

Group I: MYK-491 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

MyoKardia, Inc.

Lead Sponsor

Trials

13

Recruited

1,000+

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

In a study involving 22 patients with dilated cardiomyopathy, the addition of diltiazem to standard therapy significantly improved survival rates, with no deaths in the diltiazem group over a mean follow-up of 15.4 months, compared to a mean survival of 29 months in historical controls.

Diltiazem treatment also led to a significant increase in left ventricular ejection fraction from 0.34 to 0.44 and improved symptoms according to the New York Heart Association classification, indicating its beneficial effects on heart function and patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Beneficial long-term effects of diltiazem on the course of dilated cardiomyopathy]. Figulla, HR., von Rechenberg, J., Wiegand, V., et al.[2013]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The combined use of kinesio- and laser therapy in the regional hemodynamic disorders correction in dilated cardiomyopathy]. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Interventional study of diltiazem in dilated cardiomyopathy: a report of multiple centre clinical trial in China. Chinese Cooperative Group of Diltiazem Intervention Trial in Dilated Cardiomyopathy. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Beneficial long-term effects of diltiazem on the course of dilated cardiomyopathy]. [2013]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of dilated cardiomyopathy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Current understanding and management of dilated cardiomyopathy in Duchenne and Becker muscular dystrophy. [2021]