A Biomarker and MRI Study on Troponin Release After Exercise in Hypertrophic Cardiomyopathy
This trial is active, not recruiting.
|Sponsor||Heartcenter, University Medical Center St. Radboud|
|Start date||April 2012|
|End date||December 2020|
|Trial size||81 participants|
|Trial identifier||NCT01559714, NL37776.091.11|
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.
Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC and ACCF/AHA guidelines
Individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy
Troponin levels at baseline and troponin rise after exercise testing using a high sensitivity-troponin (hs-troponin) assay
time frame: Baseline, 6 and 24 hours after exercise
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)
time frame: Baseline
Male or female participants at least 18 years old.
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.
|Official title||BE STRONG HCM: Biomarkers, Exercise Stress Testing, and mRi to Obtain New insiGhts in Hypertrophic CardioMyopathy Study|
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