A Biomarker and MRI Study on Troponin Release After Exercise in Hypertrophic Cardiomyopathy

BE STRONG HCM: Biomarkers, Exercise Stress Testing, and mRi to Obtain New insiGhts in Hypertrophic CardioMyopathy Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01559714

Acronym

BE STRONG HCM

Enrollment

Registered

2012-03-21

Start date

2012-04-30

Completion date

2019-05-01

Last updated

2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

Keywords

Troponin, Exercise, MRI

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Troponin levels at baseline and troponin rise after exercise testing using a high sensitivity-troponin (hs-troponin) assay	Baseline, 6 and 24 hours after exercise

Secondary

Measure	Time frame
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

Countries

Netherlands

Outcome results