Risk Stratification in Children and Adolescents With Primary Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Cardiomyopathy Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Left Ventricular Noncompaction Restrictive Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathy

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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Index patients

Patients ≤18 years with primary cardiomyopathy

No interventions assigned to this group

First-degree family members

Parents and siblings of index patients

No interventions assigned to this group

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No