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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Heartcenter, University Medical Center St. Radboud.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
D.H.F. Gommans, MD, Heartcenter, University Medical Center St. Radboud
ClinicalTrials.gov Identifier:
NCT01559714
First received: March 19, 2012
Last updated: April 21, 2012
Last verified: April 2012
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2012
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559714

Locations
Netherlands
Heartcenter, University Medical Center St. Radboud Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: DHF Gommans, MD       f.gommans@cardio.umcn.nl   
Sponsors and Collaborators
Heartcenter, University Medical Center St. Radboud
  More Information

No publications provided

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
Study First Received: March 19, 2012
Last Updated: April 21, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Heartcenter, University Medical Center St. Radboud:
Troponin
Exercise
MRI

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

ClinicalTrials.gov processed this record on November 20, 2014