Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMay 15, 2013
May 1, 2013
1.3 years
February 11, 2011
May 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
cardiac fibrosis (area in cm^2) on late contrast enhanced MR images
at subject enrollment (cross-sectional design)
Secondary Outcomes (7)
systolic/diastolic function and contractility measured by echocardiography
at subject enrollment (cross-sectional design)
various parameters of cardiac function and morphology assessed with MRI and echocardiography
at subject enrollment (cross-sectional design)
anthropometric data
at subject enrollment (cross-sectional design)
VO2max
at subject enrollment (cross-sectional design)
resting-ECG
at subject enrollment (cross-sectional design)
- +2 more secondary outcomes
Study Arms (2)
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
2
15 healthy male volunteers, matched for age and bmi, without a history of competitive physical exercise (i.e. sedentary controls)
Interventions
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)
Eligibility Criteria
residents of Switzerland, either with history of national competitive endurance running (cases) or without history of endurance running (controls)
You may qualify if:
- Age 40-65y
- Healthy
- history of national competitive endurance running (cases)
- no history of endurance running (controls)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
Bern, CH-3010, Switzerland
Biospecimen
serum, plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Ith, PhD, PhD/MD
Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
- PRINCIPAL INVESTIGATOR
Christoph Stettler, MD
Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 11, 2011
First Posted
February 28, 2011
Study Start
January 1, 2011
Primary Completion
May 1, 2012
Study Completion
July 1, 2012
Last Updated
May 15, 2013
Record last verified: 2013-05