Clinical trial NCT01179802: Exercise-induced Changes in Cardiac Function & Morphology
Official title: Magnetic Resonance Technique in the Assessment of Exercise-induced Long- and Short-Term Changes in Cardiac Function and Morphology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Exercise
Myocardial Contraction
Myocardial Stunning
Heart Failure
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Federal Office of Sports, Switzerland
First posted: 2010-08-11
Enrollment: 11
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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.

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 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

Primary outcomes:
measure: Quantification of edema and/or ischemic areas with MRI
timeFrame: baseline
measure: Quantification of edema and/or ischemic areas with MRI
timeFrame: 24h post-marathon
measure: Quantification of edema and/or ischemic areas with MRI
timeFrame: 5 days post-marathon
measure: Quantification of edema and/or ischemic areas with MRI
timeFrame: 8 days post-marathon
Secondary outcomes:
measure: anthropometric data, VO2max, resting-ECG, stress-ECG, blood analyses
timeFrame: at baseline
measure: Cardiac contractility by echocardiography
timeFrame: 1h post-marathon
measure: Cardiac contractility by echocardiography
timeFrame: 5 days post-marathon
measure: Cardiac contractility by echocardiography
timeFrame: 8 days post-marathon
measure: Cardiac contractility by echocardiography
timeFrame: baseline
measure: various parameters of cardiac function and morphology assessed with MRI and echocardiography
timeFrame: baseline
measure: various parameters of cardiac function and morphology assessed with MRI and echocardiography
timeFrame: 1h post-marathon
measure: various parameters of cardiac function and morphology assessed with MRI and echocardiography
timeFrame: 1 day post-marathon
measure: various parameters of cardiac function and morphology assessed with MRI and echocardiography
timeFrame: 5 days post-marathon
measure: various parameters of cardiac function and morphology assessed with MRI and echocardiography
timeFrame: 8 days post-marathon
measure: Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
timeFrame: baseline
measure: Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
timeFrame: 1h post-marathon
measure: Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
timeFrame: 1 day post-marathon
measure: Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
timeFrame: 5 days post-marathon
measure: Post-exercise levels and dynamics of blood parameters indicating cardiac damage, cardiac overload , inflammation and hormonal stress response
timeFrame: 8 days post-marathon
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
Study officials:
affiliation: Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
name: Michael Ith, PhD, PhD/MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern
name: Christoph Stettler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilhelm M, Zueger T, De Marchi S, Rimoldi SF, Brugger N, Steiner R, Stettler C, Nuoffer JM, Seiler C, Ith M. Inflammation and atrial remodeling after a mountain marathon. Scand J Med Sci Sports. 2014 Jun;24(3):519-25. doi: 10.1111/sms.12030. Epub 2012 Dec 18.