Exercise-induced Changes in Cardiac Function & Morphology

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179802
• Other study ID #: KEK 005/10
• Status: Completed
• Phase: N/A
• First received: August 10, 2010
• Last updated: February 14, 2011
• Start date: July 2010
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Exercise
• Heart Failure
• Myocardial Contraction
• Myocardial Ischemia
• Myocardial Stunning

Intervention

Other:
• Strenuous Endurance exercise
"Jungfraumarathon": Mountain-Marathon with a length of 42km and a altitude-difference of approximately 1830meters.

Locations

Country	Name	City	State
Switzerland	Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Federal Office of Sports, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of edema and/or ischemic areas with MRI		baseline	No
Primary	Quantification of edema and/or ischemic areas with MRI		24h post-marathon	No
Primary	Quantification of edema and/or ischemic areas with MRI		5 days post-marathon	No
Primary	Quantification of edema and/or ischemic areas with MRI		8 days post-marathon	No
Secondary	anthropometric data, VO2max, resting-ECG, stress-ECG, blood analyses		at baseline	No
Secondary	Cardiac contractility by echocardiography		1h post-marathon	No
Secondary	Cardiac contractility by echocardiography		5 days post-marathon	No
Secondary	Cardiac contractility by echocardiography		8 days post-marathon	No
Secondary	Cardiac contractility by echocardiography		baseline	No
Secondary	various parameters of cardiac function and morphology assessed with MRI and echocardiography		baseline	No
Secondary	various parameters of cardiac function and morphology assessed with MRI and echocardiography		1h post-marathon	No
Secondary	various parameters of cardiac function and morphology assessed with MRI and echocardiography		1 day post-marathon	No
Secondary	various parameters of cardiac function and morphology assessed with MRI and echocardiography		5 days post-marathon	No
Secondary	various parameters of cardiac function and morphology assessed with MRI and echocardiography		8 days post-marathon	No
Secondary	Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response		baseline	No
Secondary	Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response		1h post-marathon	No
Secondary	Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response		1 day post-marathon	No
Secondary	Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response		5 days post-marathon	No
Secondary	Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response		8 days post-marathon	No