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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2019-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinical HCM patients

Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC and ACCF/AHA guidelines

No interventions assigned to this group

Pre-clinical HCM patients

Individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No