Research on inherited heart conditions in children
Inherited Cardiac cONditions In Kids: Understanding the Genetics and Outcomes of Paediatric Inherited CardiacConditions
Imperial College London · NCT05158738
This study is trying to learn more about inherited heart conditions in children and their parents by collecting health information over five years to improve understanding and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Locations | 3 sites (London and 2 other locations) |
| Trial ID | NCT05158738 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children diagnosed with inherited cardiac conditions, particularly cardiomyopathy, and their unaffected parents. Participants will enroll through an online platform called The Heart Hive, where they can upload their health data for research purposes. The study aims to collect genetic and clinical information over a five-year period to identify genetic variants and environmental factors that influence disease progression and treatment response. By analyzing this data, the researchers hope to enhance understanding of these rare conditions and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include children under 16 years with a confirmed diagnosis of cardiomyopathy or other rare inherited cardiac conditions, along with their parents.
Not a fit: Patients over 16 years old or those with significant secondary causes of cardiac dysfunction are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of inherited cardiac conditions in children.
How similar studies have performed: Other studies focusing on genetic factors in inherited cardiac conditions have shown promise, indicating that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
London and 2 other locations
- Royal Brompton Hospital — London, United Kingdom (RECRUITING)
- Great Ormond Street Hospital for Children — London, United Kingdom (RECRUITING)
- Harefield Hospital — Uxbridge, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: James Ware — Imperial College London
- Study coordinator: Katherine Josephs
- Email: k.josephs@imperial.ac.uk
- Phone: 0207 594 9459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inherited Cardiac Conditions, Cardiovascular Diseases