Marathon, Genetics, Inflammation and the Cardiovascular System: MAGIC-Trial

Not Applicable

Completed

• Conditions: Heart Failure; Sudden Cardiac Death

• Registration Number: NCT00845286
• Lead Sponsor: Technical University of Munich

Brief Summary

The purpose of the study is to determine the myocardial function and vascular adaptation after strenuous exercise in association with genotype/polymorphisms. We aim to investigate the effects of extreme endurance exercise on the cardiovascular system. Furthermore, the role of the inflammatory response and adaptive mechanisms of the vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being investigated.

Detailed Description

Regular exercise leads to an improvement of cardiovascular risc factors in patients with coronary heart disease, atherosclerosis and metabolic disorders. Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.

We aim to define the critical role of inflammatory markers and cardiovascular risc factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.

Diagnostic tools include measurements of augmentation index (AIx), arteriolar-venular ratio (AVR) and, for the first time, 2D and 3D echocardiographic measurements such as TDI-imaging and speckle tracking. Inflammatory markers include c-reactive protein (CRP), interleukins and tumor necrosis factor. Additionally, cardiovascular markers are measured. All variations are analysed on the basis of genotype characteristics/polymorphisms.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2009-02-16
• Study First Posted: 2009-02-18
• Primary Completion: 2014-03
• Study Completion: 2014-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 162

Inclusion Criteria

• men aged 30-60 years

Exclusion Criteria

• manifested heart disease
• insulin dependent diabetes mellitus
• multi drug therapy
• GFR<60ml/min.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
E/A ratio	pre-, post-, one day follow-up

Secondary Outcome Measures

Name	Time	Method
LV twist	pre-, post-, one day follow-up

Trial Locations

Locations (1)

Department of Prevention and Sports medicine; 🇩🇪 Munich, Bavaria, Germany