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OpenTrials
Completed

NCT Number: NCT01559714

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heartcenter, University Medical Center St. Radboud

Nijmegen, Gelderland, 6525 GA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Heartcenter, University Medical Center St. Radboud

Other

Registry information

Official study title

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

Acronym: BE STRONG HCM

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2012
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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