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A Biomarker and MRI Study on Troponin Release After Exercise in Hypertrophic Cardiomyopathy (BE STRONG HCM)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559714
First Posted: March 21, 2012
Last Update Posted: August 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
D.H.F. Gommans, MD, Heartcenter, University Medical Center St. Radboud
  Purpose

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.


Condition
Hypertrophic Cardiomyopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BE STRONG HCM: Biomarkers, Exercise Stress Testing, and mRi to Obtain New insiGhts in Hypertrophic CardioMyopathy Study

Resource links provided by NLM:


Further study details as provided by D.H.F. Gommans, MD, Heartcenter, University Medical Center St. Radboud:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: April 2012
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Clinical HCM patients
Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC and ACCF/AHA guidelines
Pre-clinical HCM patients
Individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of clinical or pre-clinical HCM patients that are registered in the HCM database of the HCM outpatient clinic of University Medical Center St. Radboud. This database will be screened for eligible patients according to the in- and exclusion criteria described below.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559714


Locations
Netherlands
Heartcenter, University Medical Center St. Radboud
Nijmegen, Gelderland, Netherlands, 6525 GA
Sponsors and Collaborators
Heartcenter, University Medical Center St. Radboud
  More Information

Responsible Party: D.H.F. Gommans, MD, Principal Investigator, Heartcenter, University Medical Center St. Radboud
ClinicalTrials.gov Identifier: NCT01559714     History of Changes
Other Study ID Numbers: NL37776.091.11
First Submitted: March 19, 2012
First Posted: March 21, 2012
Last Update Posted: August 16, 2016
Last Verified: August 2016

Keywords provided by D.H.F. Gommans, MD, Heartcenter, University Medical Center St. Radboud:
Troponin
Exercise
MRI

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases