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

NCT01559714 | Completed

• 1 other identifier: NL37776.091.11
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

Troponin; Exercise; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Heartcenter, University Medical Center St. Radboud: lead

Study Sites (1)

Heartcenter, University Medical Center St. Radboud

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Motor Activity

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 21, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

NL (1)