NCT06446271 Biomarkers in SCOTland CardiomyopatHy Registry (Bio-SCOTCH)
| NCT ID | NCT06446271 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NHS Greater Glasgow and Clyde |
| Condition | Cardiomyopathies |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2024-06-26 |
| Primary Completion | 2027-03-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 750 participants in total. It began in 2024-06-26 with a primary completion date of 2027-03-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Genetic cardiomyopathy is increasingly recognised and can lead to heart failure, arrhythmia and sudden cardiac death. Some gene positive patients have rapidly progressive disease with high rates of heart failure and cardiac transplantation, while others present with SCD. Other gene positive patients will never develop cardiomyopathy. At present, we cannot distinguish between these groups and rely on expensive and labour-intensive surveillance by electrocardiography, echocardiography and sometimes cardiac magnetic resonance imaging. This study will investigate existing and novel biomarkers (including blood, urine electrocardiographic and imaging) at various stages of disease in patients with a personal or family history of TTN, MYBPC3, LMNA, FLNC or DSP gene variant, which are known to cause cardiomyopathy.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06446271 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, studying Cardiomyopathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06446271 currently recruiting?
Yes, NCT06446271 is actively recruiting participants. Contact the research team at Caroline.Coats@glasgow.ac.uk for enrollment information.
Where is the NCT06446271 trial being conducted?
This trial is being conducted at Glasgow, United Kingdom.
Who is sponsoring the NCT06446271 clinical trial?
NCT06446271 is sponsored by NHS Greater Glasgow and Clyde. The trial plans to enroll 750 participants.