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

Completed

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT01559714
• Lead Sponsor: Heartcenter, University Medical Center St. Radboud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Study Start: 2012-04
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-06
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Heartcenter, University Medical Center St. Radboud; 🇳🇱 Nijmegen, Gelderland, Netherlands