Inherited Cardiac ConditionsICONIKNCT05158738
Inherited Cardiac cONditions In Kids
An observational study of Inherited Cardiac Conditions and Cardiovascular Diseases, run by Imperial College London at 3 sites in United Kingdom.
Trial summary
All patients with heart disease should have the opportunity to participate in research into their condition, to advance knowledge and treatment. The investigators have built an online registry and database - The Heart Hive - to connect research-willing participants (with heart muscle disease) with active researchers… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inherited Cardiac Conditions, Cardiovascular Diseases
- What is being tested?
- Patients with inherited cardiac condition, onset <16 years old and Parents
- How many people
- 300 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Sep 2022to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chief Investigator contact
United Kingdom3 sites, 3 recruiting
- Recruiting
Royal Brompton Hospital
London, SW3 6NP
Jemilat Orlandy, 07756223595, j.orlandy@rbht.nhs.uk
Piers Daubeney, Professor
- Recruiting
Great Ormond Street Hospital for Children
London
Angharad Roberts, Dr, angharad.roberts@imperial.ac.uk
Angharad Roberts, Dr
- Recruiting
Harefield Hospital
Uxbridge, UB9 6JH
Jemilat Orlandy, 07756223595, j.orlandy@rbht.nhs.uk
Andres Rico-Armada, Dr
About this study
Official title: Inherited Cardiac cONditions In Kids: Understanding the Genetics and Outcomes of Paediatric Inherited CardiacConditions
All patients with heart disease should have the opportunity to participate in research into their condition, to advance knowledge and treatment. The investigators have built an online registry and database - The Heart Hive - to connect research-willing participants (with heart muscle disease) with active researchers and projects. Participants enrol and upload their own data through the website.This study uses The Heart Hive platform to study cardiomyopathies - heart muscle disease. These are progressive diseases, and there is a need to better understand what factors affect the chances of developing cardiomyopathy, and how the condition progresses. The study will collect information about participants diagnosis, DNA for genetic analysis, and then follow participants' clinical progress. The study will identify genetic variants that cause cardiomyopathy, and determine which specific genetic or environmental factors predict disease severity, progression and response to treatment, with an overall objective of identifying new and personalised treatments for patients with this disease.
Read the 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.
- Being tested
- Patients with inherited cardiac condition, onset <16 years old and Parents
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with inherited cardiac condition, onset <16 years old and ParentsOther
Patients with a confirmed diagnosis of an inherited cardiac condition, onset <16 years old and Parents will have samples that undergo whole genome sequencing and biomarker analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures
Identification of novel genetic variants associated with disease status or outcome
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start1 Sep 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inherited Cardiac ConditionsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- James Ware, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158738
- Sponsor's protocol ID
- 288514
- Acronym
- ICONIK
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2021
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data dictionaries will be shared with collaborating sites
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inherited Cardiac cONditions In Kids: Understanding the Genetics and Outcomes of Paediatric Inherited CardiacConditions
- ClinicalTrials.gov ID
- NCT05158738
- Acronym / sponsor ID
- ICONIK / 288514
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Dec 2021 (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.
All patients with heart disease should have the opportunity to participate in research into their condition, to advance knowledge and treatment. The investigators have built an online registry and database - The Heart Hive - to connect research-willing participants (with heart muscle disease) with active researchers and projects. Participants enrol and upload their own data through the website.This study uses The Heart Hive platform to study cardiomyopathies - heart muscle disease. These are progressive diseases, and there is a need to better understand what factors affect the chances of developing cardiomyopathy, and how the condition progresses. The study will collect information about participants diagnosis, DNA for genetic analysis, and then follow participants' clinical progress. The study will identify genetic variants that cause cardiomyopathy, and determine which specific genetic or environmental factors predict disease severity, progression and response to treatment, with an overall objective of identifying new and personalised treatments for patients with this disease.
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with inherited cardiac condition, onset <16 years old and ParentsPatients with a confirmed diagnosis of an inherited cardiac condition, onset <16 years old and Parents will have samples that undergo whole genome sequencing and biomarker analysis | Other | – |
Primary outcome
Primary outcome measures
Time frame: 5 years
Identification of novel genetic variants associated with disease status or outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Yes. Data dictionaries will be shared with collaborating sites
Related trials for Inherited Cardiac Conditions
Not yet recruitingObservational study
Using Heart Electrical Signals to Study How Well Treatments Prevent Dangerous Heart Rhythms in Active People
Inherited Cardiac Conditions, Sudden Cardiac Arrest
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.
Chief Investigator contact
James Ware principal investigator
Imperial College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inherited Cardiac Conditions and Cardiovascular Diseases, run by Imperial College London at 3 sites in United Kingdom.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Josephs (0207 594 9459, k.josephs@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measures (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.