Overview

This trial is active, not recruiting.

Condition hypertrophic cardiomyopathy
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

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.

Additional Information

Official title BE STRONG HCM: Biomarkers, Exercise Stress Testing, and mRi to Obtain New insiGhts in Hypertrophic CardioMyopathy Study
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Heartcenter, University Medical Center St. Radboud.