Primary CardiomyopathyRIKADANCT03572569
Risk Stratification in Children and Adolescents With Primary Cardiomyopathy
An observational study of Primary Cardiomyopathy and Dilated Cardiomyopathy, run by German Heart Institute at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Primary Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2013to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: Department of pediatric cardiology including outpatient department
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- unwillingness to give consent
- myocardial inflammation / myocarditis
- systemic disease with cardiac involvement (secondary cardiomyopathy)
- structural congenital heart disease
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 13353
Charité - Universitätsmedizin Berlin
Sabine Klaassen, MD
- Recruiting
German Heart Institute
Berlin, 13353
German Heart Institute
Nadya Al-Wakeel - Marquard, MD
About this study
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.
Read the 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.
- Conditions
- Primary Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Left Ventricular Noncompaction, Restrictive Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy
- Keywords
- Pediatrics, Cardiomyopathy, Heart failure, Risk stratification, Family screening, Genetics
- Medical subject headings
- Cardiomyopathies, Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Cardiomyopathy, Restrictive, Arrhythmogenic Right Ventricular Dysplasia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Index patients | Patients ≤18 years with primary cardiomyopathy | |
| First-degree family members | Parents and siblings of index patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
major cardiovascular events
death, need for mechanical circulatory support or heart transplantation
Measured: from date of enrollment until the date of death, mechanical circulatory support or heart transplantation, assessed up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study startJan 2013
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Sponsor
- Investigators
- Felix Berger, MD, Principal investigator, German Heart InstituteSabine Klaassen, MD, Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572569
- Sponsor's protocol ID
- A30127
- Other IDs
- 81Z3100331
- Acronym
- RIKADA
- Status last verified
- Jun 2018
- First submitted
- 1 Jun 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35252369Al-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.
PubMed 31333075
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification in Children and Adolescents With Primary Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03572569
- Acronym / sponsor ID
- RIKADA / A30127
- Conditions
- Primary Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Left Ventricular Noncompaction, Restrictive Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy
- Keywords
- Pediatrics, Cardiomyopathy, Heart failure, Risk stratification, Family screening, Genetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index patients | – | –Patients ≤18 years with primary cardiomyopathy |
| First-degree family members | – | –Parents and siblings of index patients |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Department of pediatric cardiology including outpatient department
Key inclusion criteria (12 listed)
- Index patients:
- First-degree family members (parents and siblings):
Key exclusion criteria (4 listed)
- unwillingness to give consent
- myocardial inflammation / myocarditis
- systemic disease with cardiac involvement (secondary cardiomyopathy)
- structural congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Derived from this study: PubMed 35252369Al-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.
- Derived from this study: PubMed 31333075Al-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Berger, MD principal investigator
German Heart Institute
Sabine Klaassen, MD study director
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Cardiomyopathy and Dilated Cardiomyopathy, run by German Heart Institute at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabine Klaassen, MD (+49 30 450 ext. 540656, klaassen@mdc-berlin.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03572569, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.