- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05158738
Inherited Cardiac cONditions In Kids (ICONIK)
Inherited Cardiac cONditions In Kids: Understanding the Genetics and Outcomes of Paediatric Inherited CardiacConditions
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a multi-centre, observational study of children with rare inherited cardiac conditions. The focus of the study will be on children with clinically diagnosed cardiomyopathy and their unaffected parents, with collection of baseline demographic data, imaging data, and genotyping data. Children and their parents will been rolled over a 5-year period.
Sub-sets of patients with confirmed diagnoses of other heritable cardiovascular diseases with onset <16 years will also be recruited.These will include children who following evaluation by their clinical multidisciplinary team (which will include a geneticist or genetic counsellor) are likely to have a rare monogenic condition. Other affected family members of eligible patients may be also invited to participate in the study.
Information for this study will be collected primarily from investigations performed as part of the participants' routine clinical care including whole genome sequencing commissioned by NHS England. The study will seek consent to access and export this data. Procedures performed as part of this study may include venepuncture and/or saliva collection and carry minimal risk to the patient.
Parents of participants that are recruited into the study will donate a blood sample (or saliva sample if unable to provide blood) and consent will be requested for collection of health information and results of relevant investigations carried out as part of their routine clinical care (e.g. an echocardiogram). Other family members that are recruited into the study will donate a blood sample (or saliva sample if unable to provide blood) and consent will be requested for collection of health information. Family members of deceased patients with cardiomyopathy or other inherited cardiac conditions may be asked if they wish to donate stored samples that may have been taken prior to death or as part of a post-mortem examination to establish cause of death. Any discussion with regard to the use of stored samples for this project will be initiated by the clinical care team for the deceased patient and their family to minimise any potential distress to the family. Sub-sets of patients may be asked to donate tissue samples taken as part of their clinical care.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Katherine Josephs
- Phone Number: 0207 594 9459
- Email: k.josephs@imperial.ac.uk
Study Contact Backup
- Name: Chief Investigator
- Phone Number: 0330 128 2294
Study Locations
-
-
-
London, United Kingdom, SW3 6NP
- Recruiting
- Royal Brompton Hospital
-
Contact:
- Jemilat Orlandy
- Phone Number: 07756223595
- Email: j.orlandy@rbht.nhs.uk
-
Principal Investigator:
- Piers Daubeney, Professor
-
London, United Kingdom
- Recruiting
- Great Ormond Street Hospital for Children
-
Contact:
- Angharad Roberts, Dr
- Email: angharad.roberts@imperial.ac.uk
-
Principal Investigator:
- Angharad Roberts, Dr
-
Uxbridge, United Kingdom, UB9 6JH
- Recruiting
- Harefield Hospital
-
Contact:
- Jemilat Orlandy
- Phone Number: 07756223595
- Email: j.orlandy@rbht.nhs.uk
-
Principal Investigator:
- Andres Rico-Armada, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Males or females with a confirmed diagnosis of childhood onset (<16 years) PCM and their parents.
- Males or females with childhood onset (<16 years) of a rare inherited cardiac condition likely to be a monogenic condition and their parents.
Description
Inclusion Criteria:
- Males or females with a confirmed diagnosis of childhood onset (<16 years) PCM
- Males or females with childhood onset (<16 years) of a rare inherited cardiac condition likely to be a monogenic condition
- Capacity for parents to provide informed consent
- Genotype negative following local standard diagnostic ICC gene panel
- Family members of patients with ICC, both affected and unaffected
Exclusion Criteria:
- Parents who lack capacity to provide consent on behalf of their children/themselves
- Onset over 16 years
- Significant teratogen exposure (including maternal diabetes) likely to contribute to cardiac dysfunction (following discussion with Cardiologist)
- Significant coronary heart disease likely to contribute to cardiac dysfunction (following discussion with Cardiologist)
- Other secondary causes of cardiac dysfunction likely to explain the phenotype of the patient
- Patients with a confirmed genetic diagnosis (patients with variants of uncertain significance are not excluded).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary outcome measures
Time Frame: 5 years
|
Identification of novel genetic variants associated with disease status or outcome
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James Ware, Imperial College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 288514
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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