Risk Stratification in Children and Adolescents With Primary Cardiomyopathy

Last updated: June 27, 2018
Sponsor: German Heart Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Cardiovascular Disease

Cardiomyopathy

Treatment

N/A

Clinical Study ID

NCT03572569
A30127
81Z3100331
  • Ages < 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 twostandard 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

  1. First-degree family members (parents and siblings):

  • Age ≥3 years

  • written informed consent of parents/legal guardians and siblings ≥18 years

Exclusion

Exclusion Criteria:

  • unwillingness to give consent

  • myocardial inflammation / myocarditis

  • systemic disease with cardiac involvement (secondary cardiomyopathy)

  • structural congenital heart disease

Study Design

Total Participants: 200
Study Start date:
January 01, 2013
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • German Heart Institute

    Berlin, 13353
    Germany

    Active - Recruiting

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