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Exercise-induced Changes in Cardiac Function & Morphology

This study has been completed.
Sponsor:
Collaborator:
Federal Office of Sports, Switzerland
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01179802
First received: August 10, 2010
Last updated: February 14, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Myocardial Ischemia
Exercise
Myocardial Contraction
Myocardial Stunning
Heart Failure
 Other: Strenuous Endurance exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Quantification of edema and/or ischemic areas with MRI [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Quantification of edema and/or ischemic areas with MRI [ Time Frame: 24h post-marathon ] [ Designated as safety issue: No ]
  • Quantification of edema and/or ischemic areas with MRI [ Time Frame: 5 days post-marathon ] [ Designated as safety issue: No ]
  • Quantification of edema and/or ischemic areas with MRI [ Time Frame: 8 days post-marathon ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anthropometric data, VO2max, resting-ECG, stress-ECG, blood analyses [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • Cardiac contractility by echocardiography [ Time Frame: 1h post-marathon ] [ Designated as safety issue: No ]
  • Cardiac contractility by echocardiography [ Time Frame: 5 days post-marathon ] [ Designated as safety issue: No ]
  • Cardiac contractility by echocardiography [ Time Frame: 8 days post-marathon ] [ Designated as safety issue: No ]
  • Cardiac contractility by echocardiography [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • various parameters of cardiac function and morphology assessed with MRI and echocardiography [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • various parameters of cardiac function and morphology assessed with MRI and echocardiography [ Time Frame: 1h post-marathon ] [ Designated as safety issue: No ]
  • various parameters of cardiac function and morphology assessed with MRI and echocardiography [ Time Frame: 1 day post-marathon ] [ Designated as safety issue: No ]
  • various parameters of cardiac function and morphology assessed with MRI and echocardiography [ Time Frame: 5 days post-marathon ] [ Designated as safety issue: No ]
  • various parameters of cardiac function and morphology assessed with MRI and echocardiography [ Time Frame: 8 days post-marathon ] [ Designated as safety issue: No ]
  • Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response [ Time Frame: 1h post-marathon ] [ Designated as safety issue: No ]
  • Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response [ Time Frame: 1 day post-marathon ] [ Designated as safety issue: No ]
  • Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response [ Time Frame: 5 days post-marathon ] [ Designated as safety issue: No ]
  • Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response [ Time Frame: 8 days post-marathon ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: July 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
single event of a prolonged strenuous endurance exercise (mountain marathon)
 Other: Strenuous Endurance exercise
"Jungfraumarathon": Mountain-Marathon with a length of 42km and a altitude-difference of approximately 1830meters.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179802

Locations
Switzerland
Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
Bern, Switzerland, CH-3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Federal Office of Sports, Switzerland
Investigators
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
  More Information

No publications provided

Responsible Party: Dr.phil.nat. Dr.sci.med. Michael Ith, Dept. of Diagnostic, Interventional and Pediatric Radiology (DIPR) University & Inselspital Bern
ClinicalTrials.gov Identifier: NCT01179802     History of Changes
Other Study ID Numbers: KEK 005/10
Study First Received: August 10, 2010
Last Updated: February 14, 2011
Health Authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Heart Failure
Ischemia
Myocardial Stunning
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Myocardial Infarction

ClinicalTrials.gov processed this record on June 18, 2013