A Biomarker and MRI Study on Troponin Release After Exercise in Hypertrophic Cardiomyopathy

Study Overview
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Brief Summary
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Study population: 1) mutation carriers without the hypertrophic phenotype (pre-clinical Hypertrophic Cardiomyopathy (HCM)) and in 2) patients with clinically overt HCM (clinical HCM). Hypothesis: Cardiac troponin release after exercise can be demonstrated in both clinical and pre-clinical HCM patients.

Official Title
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BE STRONG HCM: Biomarkers, Exercise Stress Testing, and mRi to Obtain New insiGhts in Hypertrophic CardioMyopathy Study

Conditions
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Hypertrophic Cardiomyopathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC guidelines or individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy (pre-clinical HCM patients); Age ≥ 18 years; Able to comply with the protocol; Written informed consent. Exclusion Criteria: Known significant epicardial coronary artery disease; Patients with LVH in the clinical setting of other disorders that explain the myocardial hypertrophy (amyloidosis, MELAS, Anderson-Fabry, WPW etc.); Heart failure NYHA class III-IV; Patients with known hemodynamic instability or syncope during exercise due to left ventricular outflow gradient or occurrence of ventricular arrhythmia; History of PTSMA (percutaneous transluminal septal myocardial ablation) or Morrow myectomy; Patients not able to complete a bicycle test; Any contraindication to MR imaging (MR imaging is not obligatory for assessment of the primary objective, therefore relative exclusion criterion); Recent (within 30 days) admittance to the hospital for any cardiac reason (myocardial infarction, heart failure, cardiac arrhythmia, etc.); Severe renal insufficiency (eGFR < 30 ml/min); Any other condition which, in the opinion of the investigator, may pose a significant hazard to the subject if he or she participates in the present study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical HCM patients<br>Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC and ACCF/AHA guidelines | |
| Pre-clinical HCM patients<br>Individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin levels at baseline and troponin rise after exercise testing using a high sensitivity-troponin (hs-troponin) assay |  | Baseline, 6 and 24 hours after exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between troponin levels and phenotypic characteristics assessed with MRI (LV volumes, mass and ejection fraction, presence of LGE and/or elevated signal on T2-weighted imaging) |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Troponin, Exercise, MRI