Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology

NCT ID: NCT01305304

Last Updated: 2013-05-15

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Until now it has been assumed that regular endurance training has a positive influence on cardiac function and that the positive effect increases with increasing intensity. However, little is known about the effects of intense endurance stress on the heart. According to current knowledge repeated exposure to strenuous endurance activity may lead to minor but possibly irreversible damage to the heart with resultant scarring of the heart's muscle.

Within this study the investigators attempt to find out by different analytical methods - in particular magnetic resonance imaging (MRI) and ultrasound of the heart - to what extent the heart muscle is affected by long term intense endurance exercise and which changes in cardiac function and morphology can possibly be found. Therefore the investigators compare former national competitive endurance athletes with sedentary controls.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background

Despite the well documented cardio-protective effects of aerobic exercise of moderate intensity, short- and long-term consequences of strenuous exercise are less clear. There is increasing evidence that maintaining a high cardiac workload over a prolonged duration may result in transient impairment of cardiac function. Recent studies have also reported a transient increase in cardiac biomarkers after prolonged strenuous exercise. While in patients with cardiac disease the presence of cardiac dysfunction and increased cardiac biomarkers generally reflects myocardial damage, the impact of these observations in athletes is ill defined. It is a matter of concern whether in athletes such findings simply reflect a reversible response or whether repetitive events may lead to an accumulative cardiac damage. Traditional echocardiographic methods used to determine potential cardiac changes in morphology or function are investigator-dependent and may be subject to interference by cardiac pre- and afterload. Cardiac magnetic resonance imaging provides an investigator-independent and objective method to quantify cardiac dimensions and function. Delayed contrast enhancement MR imaging is a highly reproducible cardiovascular magnetic resonance imaging technique to directly visualize myocardial edema, necrosis and fibrosis.

Objective

To use cardiac and delayed contrast enhancement magnetic resonance imaging in combination with echocardiographic methods to to assess whether athletes involved in prolonged strenuous exercise over years reveal persistent alterations of cardiac morphology and function.

Methods

Cardiac and delayed contrast enhancement magnetic resonance imaging will be used in combination with echocardiographic methods to investigate whether involvement in prolonged strenuous exercise over years leads to changes in cardiac function and morphology. Therefore we study and compare 15 veteran elite athletes and 15 sedentary controls. The use of cardiac MRI and delayed contrast enhancement magnetic resonance imaging techniques will be paralleled by echocardiographic and tissue Doppler measurements to allow comparative analyses of the two methods.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Ischemia Myocardial Infarction Ventricular Remodeling Myocardial Contraction Ventricular Hypertrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

15 healthy male "veteran" runners (marathon, triathlon, orienteering) aged between 40 and 65 years with a history of competitive running at a national level during a period of at least 5 years, implicating normally a runner career with at least 50km per week over more than 10 years

repeated long term endurance exercise

Intervention Type OTHER

competitive running at a national level during a period of at least 5 years (i.e. approximately 50km per week over more than 10 years)

2

15 healthy male volunteers, matched for age and bmi, without a history of competitive physical exercise (i.e. sedentary controls)

Other

Intervention Type OTHER

No history of endurance sports activity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

repeated long term endurance exercise

competitive running at a national level during a period of at least 5 years (i.e. approximately 50km per week over more than 10 years)

Intervention Type OTHER

Other

No history of endurance sports activity

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 40-65y
* Healthy
* history of national competitive endurance running (cases)
* no history of endurance running (controls)

Exclusion Criteria

* Contraindication for MRI
* History of relevant cardiac disease (including cardiomyopathies)
* coronary heart disease
* coronary abnormalities
* cardiovascular risk factors
* History of any chronic disease
* drug abuse
* Arrhythmias which make adequate echocardiography unfeasible (such as atrial fibrillation or bundle-branch blocks)
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal Office of Sports, Switzerland

OTHER_GOV

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dept. of Diagnostic, Interventional and Pediatric Radiology (DIPR) University & Inselspital Bern

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Ith, PhD, PhD/MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern

Christoph Stettler, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern

Bern, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KEK 005/010 B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.