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Identification of biomarkers of hypertrophic cardiomyopathy development and progression in Dutch MYBPC3 founder mutation carriers

Recruiting
Conditions
hypertrophic cardiomyopathy / thick heart muscle
10028593
10007510
Registration Number
NL-OMON47925
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
1000
Inclusion Criteria

MYBPC3 founder mutation carrier and 18 years or older

Exclusion Criteria

Cardiac transplant

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Main study determinants/potential predictors<br /><br>- Age (at carrier diagnosis)<br /><br>- Gender<br /><br>- cMyBP-C protein content in exosomes isolated from plasma<br /><br>- creatine/guanidine acetic acid ratio in plasma<br /><br>- delta creatine/guanidine acetic acid ratio in plasma prior/after exercise test<br /><br>- acylcarnitine profile in plasma<br /><br>- delta acylcarnitine profile in plasma prior/after exercise test<br /><br><br /><br>Dependent of the study question of the prospective cohort the endpoints are:<br /><br>1) development of severe HCM<br /><br>2) progression of HCM to severe HCM<br /><br><br /><br>For the case-control study at baseline: a severe HCM phenotype.<br /><br><br /><br>A severe cardiac phenotype will be defined as one or more of the following:<br /><br>septal thickness of >= 20 mm, cardiac arrest due to ventricular arrhythmia, LVEF<br /><br>< 40% or indication for myectomy or cardiac transplant.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>not applicable</p><br>
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