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Completed

NCT Number: NCT04166903

Prospective Follow-up, Marathon, Long Term, Inflammation and Cardiovascular System

Pro-MagIC is a prospective observational study and includes participants of the Be-MaGIC-Study 2009 (n=277/NCT00933218). We aim to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years.

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Key information

Age range

30 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany

Munich, Bavaria, 80992, Germany

About this study

Physical activity is associated with health benefits. Acute prolonged and strenuous exercise, i.e. Marathon running, leads to hemodynamic, endothelial and myocardial functional changes. Whether these myocardial, endothelial and hemodynamic changes can also develop and persist through repetitive extreme and prolonged physical activity is currently still a matter of controversy. In addition, it is not known whether adaptations and changes over time can develop into clinically relevant cardiovascular events with negative health consequences in healthy athletes. The aim of this study is to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years.

For this purpose, 277 male participants from the Be-MaGIC study (Marathon 2009) are examined in this prospective observational study. A single examination with the following components will take place: Anthropometry, clinical examination, laboratory, resting / exercise electrocardiography cardiopulmonary stress test, echocardiography, and fundus camera. Further examinations will be conducted in participants with abnormal examination results in line with current clinical recommendations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Declaration of consent Participants must have participated in the Be-MaGIC study in 2009

  • current age: 30 - 70 years
  • sex: male

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Changes of right ventricular systolic function (RV-EF)

    Time frame: 10 years

    Echocardiography

Secondary outcomes

  1. Changes in left ventricular ejection fraction (LV-EF)

    Time frame: 10 years

    Echocardiography

  2. Changes in left ventricular diastolic function (E/e´)

    Time frame: 10 years

    Echocardiography

  3. Change in cardiac markers (e.g. cardiac Troponin)

    Time frame: 10 years

    Clinical chemistry (blood samples)

  4. Change in inflammation markers (e.g. C-reactive Protein)

    Time frame: 10 years

    Clinical chemistry (blood samples)

  5. Change in microcirculation (e.g. arteriolar-to-venular ratio)

    Time frame: 10 years

    Static Retinal Vessel Analyzer

  6. Change in macrocirculation (e.g. Intima media thickness)

    Time frame: 10 years

    Carotid sonography

  7. Change of prevalence of cardiovascular diseases

    Time frame: 10 years

    Questionnaire

  8. Association between changes of aforementioned parameters (see Topics 1-8) and potential underlying causes (e.g. sports history like number of ultraendurance competitions) in the examined cohort

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Balgrist University Hospital
  • Deutsches Herzzentrum Muenchen

Registry information

Official study title

Prospective Long Term Follow-up Analysis of Exercise-induced Physiological Changes in Male Runners

Acronym: Pro-MagIC

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 18, 2019
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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