Hypertrophic Cardiomyopathy Clinical Trial
— RIKADAOfficial title:
Risk Stratification in Children and Adolescents With Primary Cardiomyopathy
RIKADA is a prospective study performing systematic family screening including clinical and genetic testing in pediatric patients with primary cardiomyopathy and their first-degree relatives with the aim to facilitate risk stratification.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: 1. Index patients: - Age =18 years - written informed consent of parents/legal guardians - diagnosis of primary cardiomypathy: - DCM: left ventricular (LV) systolic dysfunction and dilatation greater than two standard deviations (SD) above the mean of a normal population - HCM: LV hypertrophy and septal wall thickness above two SD - RCM: diastolic dysfunction and concordant atrial enlargement - LVNC: separation of the myocardium into a compacted (C) and a non- compacted (NC) layer with an NC/C ratio >2 in echocardiography and/or >2.3 in CMR - ARVC: according to the revised Task Force Criteria 2. First-degree family members (parents and siblings): - Age =3 years - written informed consent of parents/legal guardians and siblings =18 years Exclusion Criteria: - unwillingness to give consent - myocardial inflammation / myocarditis - systemic disease with cardiac involvement (secondary cardiomyopathy) - structural congenital heart disease |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
Germany | German Heart Institute | Berlin |
Lead Sponsor | Collaborator |
---|---|
German Heart Institute | Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | major cardiovascular events | death, need for mechanical circulatory support or heart transplantation | from date of enrollment until the date of death, mechanical circulatory support or heart transplantation, assessed up to 8 years |
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