A Biomarker and MRI Study on Troponin Release After Exercise in Hypertrophic Cardiomyopathy (BE STRONG HCM)
Verified March 2015 by Heartcenter, University Medical Center St. Radboud
Information provided by (Responsible Party):
D.H.F. Gommans, MD, Heartcenter, University Medical Center St. Radboud
First received: March 19, 2012
Last updated: March 17, 2015
Last verified: March 2015
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.
||Observational Model: Cohort
Time Perspective: Prospective
||BE STRONG HCM: Biomarkers, Exercise Stress Testing, and mRi to Obtain New insiGhts in Hypertrophic CardioMyopathy Study
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2020 (Final data collection date for primary outcome measure)
Clinical HCM patients
Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC and ACCF/AHA guidelines
Pre-clinical HCM patients
Individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
The study population will consist of clinical or pre-clinical HCM patients that are registered in the HCM database of the HCM outpatient clinic of University Medical Center St. Radboud. This database will be screened for eligible patients according to the in- and exclusion criteria described below.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01559714
|Heartcenter, University Medical Center St. Radboud
|Nijmegen, Gelderland, Netherlands, 6525 GA |
|Contact: DHF Gommans, MD email@example.com |
Heartcenter, University Medical Center St. Radboud
||D.H.F. Gommans, MD, Principal Investigator, Heartcenter, University Medical Center St. Radboud
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 19, 2012
||March 17, 2015
||Netherlands: Medical Ethics Review Committee (METC)
Keywords provided by Heartcenter, University Medical Center St. Radboud:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2016
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases