TerminatedPhase 2

Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities

Stopped: Business objectives have changed

United States, Germany, Spain41 participantsStarted 2020-08-04

Plain-language summary

The purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants or other causalities.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Has adequate acoustic windows for echocardiography * Maximum of 3 family members with same variant can be enrolled * 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 Exclusion Criteria: * Significant structural cardiac abnormalities including valvar dysfunction on Screening transthoracic echo(s) * Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, afterload reduction, or diuretics) * Presence of protocol specified laboratory abnormalities at Screening * Recent acute coronary syndrome or angina pectoris (\<90 days) * Recent hospitalization for heart failure (\<90 days)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Adverse Events (AEs) in Part A

Timeframe: From first dose to 30 days post last dose (Up to approximately 15 weeks)

Number of Participants With Serious Adverse Events (SAEs) in Part A

Timeframe: From first dose to 30 days post last dose (Up to approximately 15 weeks)

Number of Participants With Safety Laboratory Assessments by Intensity in Part A

Timeframe: From first dose to 14 days post last dose (Up to approximately 13 weeks)

Number of Participants With Clinically Significant Changes in Physical Examinations in Part A

Timeframe: From first dose to 30 days post last dose (Up to approximately 15 weeks)

Number of Participants With Clinically Significant Changes in Vital Signs in Part A

Timeframe: From first dose to 30 days post last dose (Up to approximately 15 weeks)

Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A

Timeframe: From first dose to 30 days post last dose (Up to approximately 15 weeks)

Trial details

NCT IDNCT04572893

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-22

Results submitted2025-03-20

View on ClinicalTrials.gov More Primary Familial Dilated Cardiomyopathy trials