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

Heart Failure Clinical Trial

— MAGIC  

Official title:

Investigation of Myocardial Function and Vascular Adaptation in Association With Genotype in Marathon Runners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845286
• Other study ID #: 1807/07-II
• Status: Completed
• Phase: N/A
• First received: September 19, 2008
• Last updated: March 16, 2016
• Start date: September 2008
• Est. completion date: August 2014

Study information

• Verified date: March 2016
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Technical University of Munich
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• men aged 30-60 years

Exclusion Criteria:

• manifested heart disease

• insulin dependent diabetes mellitus

• multi drug therapy

• GFR<60ml/min.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

Intervention

Behavioral:
• Munich Marathon
42,195 km marathon run

Locations

Country	Name	City	State
Germany	Department of Prevention and Sports medicine	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	E/A ratio		pre-, post-, one day follow-up	Yes
Secondary	LV twist		pre-, post-, one day follow-up	Yes