Biomarkers in SCOTland CardiomyopatHy Registry (Bio-SCOTCH)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10+
SponsorNHS Greater Glasgow and Clyde
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Plasma biomarker levels
Treatment groups
750 Participants
are divided into 2 treatment groupsSponsors and collaborators
NHS Greater Glasgow and Clyde
Lead sponsor
University of Glasgow
Collaborator
Roche Diagnostics GmbH
Collaborator
Source ClinicalTrials.gov