NCT00845286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2008

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

5.5 years

First QC Date

September 19, 2008

Last Update Submit

March 16, 2016

Conditions

Heart FailureSudden Cardiac Death

Keywords

exercise, myocardial dysfunction, endothelial dysfunction,polymorphism

Outcome Measures

Primary Outcomes (1)

  • E/A ratio

    pre-, post-, one day follow-up

Secondary Outcomes (1)

  • LV twist

    pre-, post-, one day follow-up

Interventions

Munich MarathonBEHAVIORAL

42,195 km marathon run

Also known as: MAGIC

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • men aged 30-60 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Prevention and Sports medicine

Munich, Bavaria, 80809, Germany

Location

MeSH Terms

Conditions

Heart FailureDeath, Sudden, CardiacMotor Activity

Interventions

Magic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart ArrestDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Spiritual TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2008

First Posted

February 18, 2009

Study Start

September 1, 2008

Primary Completion

March 1, 2014

Study Completion

August 1, 2014

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations

DE(1)