A Biomarker and MRI Study on Troponin Release After Exercise in Hypertrophic Cardiomyopathy (BE STRONG HCM)

Heartcenter, University Medical Center St. Radboud

Status: Completed

Conditions: Hypertrophic Cardiomyopathy

Study type: Observational

Funder types: Other

Identifiers

NCT01559714

NL37776.091.11

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

81 participants in 2 patient groups

Clinical HCM patients

Description:

Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC and ACCF/AHA guidelines

Pre-clinical HCM patients

Description:

Individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy