Brief Title
Risk Stratification in Children and Adolescents With Primary Cardiomyopathy
Official Title
Risk Stratification in Children and Adolescents With Primary Cardiomyopathy
Brief Summary
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.
Detailed Description
RIKADA is a long-term prospective study performing in-depth phenotype and genotype characterization in children and adolescents with primary cardiomyopathy and their first-degree family members. Family screening contains complete cardiac work-up with medical history, physical examination, 12-lead-/Holter-electrocardiogram, cardiopulmonary exercise testing, echocardiography, cardiovascular magnetic resonance (CMR) and laboratory including genetic testing. The aim is to facilitate early identification of at-risk individuals and contribute to patient-specific follow-up and therapy regimes preventing progressive heart failure and arrhythmia in pediatric CMP.
Study Type
Observational
Primary Outcome
major cardiovascular events
Condition
Primary Cardiomyopathy
Study Arms / Comparison Groups
Index patients
Description: Patients ≤18 years with primary cardiomyopathy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
200
Start Date
January 2013
Completion Date
December 2020
Primary Completion Date
December 2020
Eligibility Criteria
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
Gender
All
Ages
N/A - 18 Years
Contacts
Felix Berger, MD, +49 30 450, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT03572569
Organization ID
A30127
Secondary IDs
81Z3100331
Responsible Party
Sponsor
Study Sponsor
German Heart Institute
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Study Sponsor
Felix Berger, MD, Principal Investigator, German Heart Institute
Verification Date
June 2018