Risk Stratification in Children and Adolescents With Primary Cardiomyopathy

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2020

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.

Arms, Groups and Cohorts

  • Index patients
    • Patients ≤18 years with primary cardiomyopathy
  • First-degree family members
    • Parents and siblings of index patients

Clinical Trial Outcome Measures

Primary Measures

  • major cardiovascular events
    • Time Frame: from date of enrollment until the date of death, mechanical circulatory support or heart transplantation, assessed up to 8 years
    • death, need for mechanical circulatory support or heart transplantation

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Investigator Details

  • Lead Sponsor
    • German Heart Institute
  • Collaborator
    • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Felix Berger, MD, Principal Investigator, German Heart Institute
    • Sabine Klaassen, MD, Study Director, Charite University, Berlin, Germany
  • Overall Contact(s)
    • Sabine Klaassen, MD, +49 30 450, klaassen@mdc-berlin.de

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