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Completed

NCT Number: NCT01179802

Exercise-induced Changes in Cardiac Function & Morphology

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 we 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 an intense endurance exercise, i.e. the "Jungfrau-Marathon", and which changes can possibly be found. Due to repeated measurements we will obtain further information on the short-term course of possible changes.

Hypotheses: A single bout of prolonged strenuous exercise (PSE) leads to transient alteration in cardiac function accompanied by the appearance of biomarkers for myocardial damage.

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Key information

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Bern, CH-3010, Switzerland

About this study

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 quantify cardiac dysfunction after a single competitive PSE event and to study post-exercise changes in morphology and function as well as the post-exercise dynamics of specific markers of myocardial damage.

Methods

Cardiac and delayed contrast enhancement magnetic resonance imaging will be used in combination with echocardiographic methods to repetitively investigate post-exercise cardiac function and morphology in 10 elite athletes finishing the "Jungfrau Marathon". Biomarkers of myocardial damage are assessed simultaneously.

Post-exercise dynamics of the outcome parameters are followed over a minimum of 7 days after the exercise.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants of the Jungfraumarathon 2010
  • Elite runners defined by their results in the Jungfraumarathon 2009 (not more than 4:30 h, corresponding to a delay of 90 minutes compared to the winner)

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

Treatment and study plan

Strenuous Endurance exercise

Other

"Jungfraumarathon": Mountain-Marathon with a length of 42km and a altitude-difference of approximately 1830meters.

Primary outcomes

  1. Quantification of edema and/or ischemic areas with MRI

    Time frame: baseline

  2. Quantification of edema and/or ischemic areas with MRI

    Time frame: 24h post-marathon

  3. Quantification of edema and/or ischemic areas with MRI

    Time frame: 5 days post-marathon

  4. Quantification of edema and/or ischemic areas with MRI

    Time frame: 8 days post-marathon

Secondary outcomes

  1. anthropometric data, VO2max, resting-ECG, stress-ECG, blood analyses

    Time frame: at baseline

  2. Cardiac contractility by echocardiography

    Time frame: 1h post-marathon

  3. Cardiac contractility by echocardiography

    Time frame: 5 days post-marathon

  4. Cardiac contractility by echocardiography

    Time frame: 8 days post-marathon

  5. Cardiac contractility by echocardiography

    Time frame: baseline

  6. various parameters of cardiac function and morphology assessed with MRI and echocardiography

    Time frame: baseline

  7. various parameters of cardiac function and morphology assessed with MRI and echocardiography

    Time frame: 1h post-marathon

  8. various parameters of cardiac function and morphology assessed with MRI and echocardiography

    Time frame: 1 day post-marathon

  9. various parameters of cardiac function and morphology assessed with MRI and echocardiography

    Time frame: 5 days post-marathon

  10. various parameters of cardiac function and morphology assessed with MRI and echocardiography

    Time frame: 8 days post-marathon

  11. Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response

    Time frame: baseline

  12. Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response

    Time frame: 1h post-marathon

  13. Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response

    Time frame: 1 day post-marathon

  14. Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response

    Time frame: 5 days post-marathon

  15. Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response

    Time frame: 8 days post-marathon

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Federal Office of Sports, Switzerland

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 11, 2010
Registry last updated
Feb 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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