Risk Stratification in Children and Adolescents With Primary Cardiomyopathy (RIKADA)

June 27, 2018 updated by: German Heart Institute
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 Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Nadya Al-Wakeel-Marquard, MD
  • Phone Number: 2883 +49 30 4593
  • Email: alwakeel@dhzb.de

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:
          • Charité - Universitätsmedizin Berlin
        • Sub-Investigator:
          • Sabine Klaassen, MD
      • Berlin, Germany, 13353
        • Recruiting
        • German Heart Institute
        • Contact:
          • German Heart Institute
        • Sub-Investigator:
          • Nadya Al-Wakeel - Marquard, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Department of pediatric cardiology including outpatient department

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from date of enrollment until the date of death, mechanical circulatory support or heart transplantation, assessed up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Heart Institute

Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Investigators

  • Principal Investigator: Felix Berger, MD, German Heart Institute
  • Study Director: Sabine Klaassen, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

June 1, 2018

First Submitted That Met QC Criteria

June 27, 2018

First Posted (ACTUAL)

June 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A30127
  • 81Z3100331 (OTHER_GRANT: DZHK (German Centre for Cardiovascular Research))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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