Danicamtiv for Dilated Cardiomyopathy

No longer recruiting at 54 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of danicamtiv for individuals with dilated cardiomyopathy (DCM). DCM enlarges and weakens the heart, and the study targets those whose condition may be linked to specific gene changes (MYH7 or TTN) or other causes. Participants must have a DCM diagnosis and be in stable condition. The researchers aim to determine if danicamtiv can improve heart function in these patients. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that danicamtiv is likely to be safe for humans?

A previous study found that danicamtiv was well tolerated by patients with dilated cardiomyopathy, a condition where the heart enlarges and struggles to pump blood effectively. The drug did not cause any unwanted side effects that led to treatment discontinuation. No serious side effects or deaths were reported, suggesting that danicamtiv has a good safety record so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for dilated cardiomyopathy, which often focus on managing symptoms with medications like beta-blockers or ACE inhibitors, danicamtiv works differently by directly targeting the heart muscle. Danicamtiv is unique because it enhances the function of myosin, a protein crucial for muscle contraction, potentially improving the heart's ability to pump blood. Researchers are excited about danicamtiv because it addresses the underlying muscle contraction issues in dilated cardiomyopathy, offering hope for a more effective treatment that could improve heart function rather than just alleviating symptoms.

What evidence suggests that danicamtiv might be an effective treatment for dilated cardiomyopathy?

Research has shown that danicamtiv, a drug that enhances heart muscle function, may hold promise for treating dilated cardiomyopathy (DCM). Studies have found that it significantly improves heart function, particularly in the main pumping chambers. Danicamtiv enhances heart contraction, improving blood flow throughout the body. Positive results have been observed in patients with DCM due to specific genetic factors, such as MYH7 or TTN variants, as well as other causes. Overall, early evidence suggests danicamtiv could be an effective treatment for individuals with DCM. ^{1 2 4 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1.

jacc.org

jacc.org/doi/10.1016/j.jacc.2025.09.1511

Danicamtiv, a selective agonist of cardiac myosin, for ...

To translationally evaluate danicamtiv in the setting of myosin dysfunction, from in vitro assessments to a clinical trial exploring its safety ...

2.

kardigan.bio

kardigan.bio/press-release/kardigan-announces-presentation-of-positive-phase-2a-data-for-danicamtiv-in-patients-with-dilated-cardiomyopathy-at-hfsa-annual-scientific-meeting-2025/

Kardigan Announces Presentation of Positive Phase 2a Data ...

“The positive Phase 2a results for danicamtiv showed clinically meaningful improvements in direct activation of both ventricular and atrial ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0735109725093738

Danicamtiv, a selective agonist of cardiac myosin, for ...

The primary endpoint was safety/tolerability; secondary endpoints included echocardiography-assessed changes in cardiac structure/function.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07210723

NCT07210723 | A Study of the Efficacy and Safety ...

The purpose of this study is to evaluate how well danicamtiv works compared to a placebo (sugar pill that looks like danicamtiv pill but does ...

5.

acc.org

acc.org/latest-in-cardiology/journal-scans/2025/09/30/13/39/new-insights-into-outcomes-with-acoramidis

New Insights Into Outcomes With Acoramidis in ATTR-CM, ...

Research highlighting acoramidis in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and danicamtiv for dilated cardiomyopathy ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04572893

Exploratory Study of Danicamtiv in Patients With Primary ...

The purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy ...

7.

bms.com

bms.com/assets/bms/shared/plain-language-summary/cv028-005/CV028-005-pls-eng-final-update-18April2025-approved.pdf

Plain Language Summary of Clinical Study Results

In this study, researchers wanted to answer the following questions: • How safe was danicamtiv for participants with primary dilated.