NCT03572569

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

7.9 years

First QC Date

June 1, 2018

Last Update Submit

June 27, 2018

Conditions

Primary CardiomyopathyDilated CardiomyopathyHypertrophic CardiomyopathyLeft Ventricular NoncompactionRestrictive CardiomyopathyArrhythmogenic Right Ventricular Cardiomyopathy

Keywords

PediatricsCardiomyopathyHeart failureRisk stratificationFamily screeningGenetics

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Index patients

Patients ≤18 years with primary cardiomyopathy

First-degree family members

Parents and siblings of index patients

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Department of pediatric cardiology including outpatient department

You may qualify if:

  • 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
  • First-degree family members (parents and siblings):
  • Age ≥3 years
  • written informed consent of parents/legal guardians and siblings ≥18 years

You may not qualify if:

  • unwillingness to give consent
  • myocardial inflammation / myocarditis
  • systemic disease with cardiac involvement (secondary cardiomyopathy)
  • structural congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

German Heart Institute

Berlin, 13353, Germany

RECRUITING

Related Publications (2)

  • Al-Wakeel-Marquard N, Seidel F, Kuhnisch J, Kuehne T, Berger F, Messroghli DR, Klaassen S. Midwall Fibrosis and Cardiac Mechanics: Rigid Body Rotation Is a Novel Marker of Disease Severity in Pediatric Primary Dilated Cardiomyopathy. Front Cardiovasc Med. 2022 Feb 17;8:810005. doi: 10.3389/fcvm.2021.810005. eCollection 2021.

    PMID: 35252369DERIVED

  • Al-Wakeel-Marquard N, Degener F, Herbst C, Kuhnisch J, Dartsch J, Schmitt B, Kuehne T, Messroghli D, Berger F, Klaassen S. RIKADA Study Reveals Risk Factors in Pediatric Primary Cardiomyopathy. J Am Heart Assoc. 2019 Aug 6;8(15):e012531. doi: 10.1161/JAHA.119.012531. Epub 2019 Jul 23.

    PMID: 31333075DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA; tissue

MeSH Terms

Conditions

CardiomyopathiesCardiomyopathy, DilatedCardiomyopathy, HypertrophicCardiomyopathy, RestrictiveArrhythmogenic Right Ventricular DysplasiaHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCardiomegalyLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital Abnormalities

Study Officials

  • Felix Berger, MD

    German Heart Institute

    PRINCIPAL INVESTIGATOR

  • Sabine Klaassen, MD

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Central Study Contacts

Sabine Klaassen, MD

CONTACT

+49 30 450klaassen@mdc-berlin.de

Nadya Al-Wakeel-Marquard, MD

CONTACT

+49 30 4593alwakeel@dhzb.de

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 28, 2018

Study Start

January 1, 2013

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

DE(2)