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

Hypertrophic Cardiomyopathy Clinical Trial

— BE STRONG HCM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559714
• Other study ID #: NL37776.091.11
• Status: Completed
• Start date: April 2012
• Est. completion date: May 1, 2019

Study information

• Verified date: July 2020
• Source: Heartcenter, University Medical Center St. Radboud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Locations

Country	Name	City	State
Netherlands	Heartcenter, University Medical Center St. Radboud	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Heartcenter, University Medical Center St. Radboud

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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