BE-STRONG HCM: Biomarkers, Exercise Stress Testing, and MRI to Obtain New InsiGhts in Hypertrophic CardioMyopathy
- Conditions
- a thickened heart muscle based on genetic predispositionHypertrophic cardiomyopathy1002859310083624
- Registration Number
- NL-OMON35538
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
•Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC guidelines;
•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.
•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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of patients (pre-clinical HCM mutation carriers and clinical HCM<br /><br>patients) with 1) a baseline troponin concentration above the upper reference<br /><br>limit (the 99th percentile) of the high-sensitivity troponin assay that will be<br /><br>used, and 2) a troponin rise after exercise testing (more than or equal to 20%<br /><br>of the baseline concentration) using the same high sensitivity-troponin assay.</p><br>
- Secondary Outcome Measures
Name Time Method