Participants of the Be-MaGIC-Study 2009Pro-MagICNCT04166903
Prospective Follow-up, Marathon, Long Term, Inflammation and Cardiovascular System
An observational study of Participants of the Be-MaGIC-Study 2009, run by Technical University of Munich at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Participants of the Be-MaGIC-Study 2009
- How many people
- 277 participants
- Where
- 1 siteGermany
- Study dates
- 15 Nov 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants of the Be-MaGIC-Study (2009)
Who may be able to join
- Declaration of consent Participants must have participated in the Be-MaGIC study in 2009
- current age: 30 - 70 years
- sex: male
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
Munich, Bavaria, 80992
About this study
Official title: Prospective Long Term Follow-up Analysis of Exercise-induced Physiological Changes in Male Runners
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.
Read the detailed description
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.
- Conditions
- Participants of the Be-MaGIC-Study 2009
- Keywords
- Prolonged exercise, marathon, cardiovascular disease, long term
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of right ventricular systolic function (RV-EF)
Echocardiography
Measured: 10 years
Secondary outcomes (8)
Changes in left ventricular ejection fraction (LV-EF)
Echocardiography
Measured: 10 years
Changes in left ventricular diastolic function (E/e´)
Echocardiography
Measured: 10 years
Change in cardiac markers (e.g. cardiac Troponin)
Clinical chemistry (blood samples)
Measured: 10 years
Change in inflammation markers (e.g. C-reactive Protein)
Clinical chemistry (blood samples)
Measured: 10 years
Change in microcirculation (e.g. arteriolar-to-venular ratio)
Static Retinal Vessel Analyzer
Measured: 10 years
Change in macrocirculation (e.g. Intima media thickness)
Carotid sonography
Measured: 10 years
Change of prevalence of cardiovascular diseases
Questionnaire
Measured: 10 years
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start15 Nov 2019
- Primary completion5 Oct 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Participants of the Be-MaGIC-Study 2009Studies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Balgrist University Hospital, Deutsches Herzzentrum Muenchen
- Responsible party
- Principal investigator, Johannes Scherr, Balgrist University Hospital
- Investigators
- Michael Schindler, MD, Study director, Department of Prevention, Rehabilitation and Sports Medicine, Munich, GermanyJohannes Scherr, MD, Principal investigator, University Hospital Balgrist, University Zurich, SwitzerlandMartin Halle, MD, Study director, Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166903
- Sponsor's protocol ID
- ProMagIC-Study
- Acronym
- Pro-MagIC
- Status last verified
- Mar 2020
- First submitted
- 13 Nov 2019
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schoenfeld J, Schindler MJ, Haller B, Holdenrieder S, Nieman DC, Halle M, La Gerche A, Scherr J. Prospective long-term follow-up analysis of the cardiovascular system in marathon runners: study design of the Pro-MagIC study. BMJ Open Sport Exerc Med. 2020 Jul 19;6(1):e000786. doi: 10.1136/bmjsem-2020-000786. eCollection 2020.
PubMed 32704381
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Long Term Follow-up Analysis of Exercise-induced Physiological Changes in Male Runners
- ClinicalTrials.gov ID
- NCT04166903
- Acronym / sponsor ID
- Pro-MagIC / ProMagIC-Study
- Conditions
- Participants of the Be-MaGIC-Study 2009
- Keywords
- Prolonged exercise, marathon, cardiovascular disease, long term
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Balgrist University Hospital, Deutsches Herzzentrum Muenchen
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of the Be-MaGIC-Study (2009)
Key inclusion criteria (3 listed)
- Declaration of consent Participants must have participated in the Be-MaGIC study in 2009
- current age: 30 - 70 years
- sex: male
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of right ventricular systolic function (RV-EF)
Time frame: 10 years
Echocardiography
8 secondary outcomes
Changes in left ventricular ejection fraction (LV-EF)
Time frame: 10 years
Changes in left ventricular diastolic function (E/e´)
Time frame: 10 years
Change in cardiac markers (e.g. cardiac Troponin)
Time frame: 10 years
Change in inflammation markers (e.g. C-reactive Protein)
Time frame: 10 years
Change in microcirculation (e.g. arteriolar-to-venular ratio)
Time frame: 10 years
Change in macrocirculation (e.g. Intima media thickness)
Time frame: 10 years
Change of prevalence of cardiovascular diseases
Time frame: 10 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 32704381Schoenfeld J, Schindler MJ, Haller B, Holdenrieder S, Nieman DC, Halle M, La Gerche A, Scherr J. Prospective long-term follow-up analysis of the cardiovascular system in marathon runners: study design of the Pro-MagIC study. BMJ Open Sport Exerc Med. 2020 Jul 19;6(1):e000786. doi: 10.1136/bmjsem-2020-000786. eCollection 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Schindler, MD study director
Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
Johannes Scherr, MD principal investigator
University Hospital Balgrist, University Zurich, Switzerland
Martin Halle, MD study director
Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Participants of the Be-MaGIC-Study 2009, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of right ventricular systolic function (RV-EF) (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04166903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.