Risk Stratification in Children and Adolescents With Primary Cardiomyopathy

Hypertrophic Cardiomyopathy Clinical Trial

— RIKADA  

Official title:

Risk Stratification in Children and Adolescents With Primary Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03572569
• Other study ID #: A30127
• Secondary ID: 81Z3100331
• Status: Recruiting
• Start date: January 2013
• Est. completion date: December 2020

Study information

• Verified date: June 2018
• Source: German Heart Institute
• Contact: Sabine Klaassen, MD
• Phone: +49 30 450
• Email: klaassen[@]mdc-berlin.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• 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

Related Conditions & MeSH terms

• Arrhythmogenic Right Ventricular Cardiomyopathy
• Arrhythmogenic Right Ventricular Dysplasia
• Cardiomyopathies
• Cardiomyopathy, Dilated
• Cardiomyopathy, Hypertrophic
• Dilated Cardiomyopathy
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Left Ventricular Noncompaction
• Primary Cardiomyopathy
• Restrictive Cardiomyopathy

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	German Heart Institute	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
German Heart Institute	Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Country where clinical trial is conducted

Germany, 

Outcome

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