Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Gene… (NCT04572893) | Clinical Trial Compass
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 States41 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 range18 Years – 80 Years
SexALL
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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)
What they're measuring
1
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)
2
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)
3
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)
4
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)
5
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)
6
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)
7
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A