Investigating biomarkers in patients with genetic cardiomyopathy
Biomarkers in SCOTland CardiomyopatHy Registry
NHS Greater Glasgow and Clyde · NCT06446271
This study is trying to find new markers in blood and other tests to help identify people with a family history of genetic heart disease who might develop symptoms, so they can be monitored more easily and effectively.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | NHS Greater Glasgow and Clyde (other) |
| Locations | 1 site (Glasgow) |
| Trial ID | NCT06446271 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on identifying existing and novel biomarkers in patients with a personal or family history of specific gene variants associated with cardiomyopathy. It aims to differentiate between individuals who will develop cardiomyopathy and those who will not, thereby improving risk stratification and clinical surveillance. By analyzing blood, urine, electrocardiographic, and imaging biomarkers, the study seeks to replace the need for frequent and costly monitoring through traditional imaging techniques. The ultimate goal is to enhance patient management and outcomes in those affected by genetic cardiomyopathy.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 10 years and older with a pathogenic or likely pathogenic variant in cardiomyopathy-related genes.
Not a fit: Patients who are unable to consent or have severe non-cardiac diseases that significantly reduce life expectancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more efficient monitoring and early detection of cardiomyopathy in genetically predisposed individuals.
How similar studies have performed: Other studies have shown promise in using biomarkers for genetic conditions, but this specific approach is novel in the context of cardiomyopathy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female ≥10 years of age * Written informed consent / assent * Pathogenic or likely pathogenic variant in a cardiomyopathy gene (TTN, LMNA, MYBPC3, DSP, FLNC) or undergoing predictive genetic testing (if negative these people would be invited to enter the control arm) Exclusion Criteria: * Unable to consent. * Geographical / social reasons preventing attending study centre * Unable to complete study assessments. * Severe non-cardiac disease expected to reduce life expectancy \< 5 years * Current participation in a blinded drug interventional trial (or treatment within 4 weeks)
Where this trial is running
Glasgow
- Queen Elizabeth University Hospital — Glasgow, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Caroline J Coats, MBBS, PhD
- Email: Caroline.Coats@glasgow.ac.uk
- Phone: 0141 451 6121
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: Cardiomyopathies, Genetic Predisposition, Cardiomyopathy, Primary, Cardiomyopathy, Genetic, Biomarkers