NCT01559714CompletedNot Applicable
BE STRONG HCM: Biomarkers, Exercise Stress Testing, and mRi to Obtain New insiGhts in Hypertrophic CardioMyopathy Study
Heartcenter, University Medical Center St. Radboud1 site in 1 country81 target enrollmentStarted: April 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Troponin levels at baseline and troponin rise after exercise testing using a high sensitivity-troponin (hs-troponin) assay
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- 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)
Investigators
D.H.F. Gommans, MD
Principal Investigator
Heartcenter, University Medical Center St. Radboud
Study Sites (1)
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