Athletes HeartFEIDIPIDISNCT04738877
Cardiovascular Effects of Marathon Running
An observational study of Athletes Heart, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The aim of this study is the investigation of acute cardiovascular responses of marathon runners after the completion of a marathon race (42.2 km), as well as of the determinants of these changes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Athletes Heart
- What is being tested?
- Body fat measurement, Cardiopulmonary exercise testing and Echocardiography
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 2 Feb 2021to 30 Aug 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Marathon runners aiming to paricipate in a marathon running race
Who may be able to join
- Marathon runner
Who cannot join
- Chronic disease, Drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FEIDIPIDIS Study: Cardiovascular Effects of Marathon Running
The aim of this study is the investigation of acute cardiovascular responses of marathon runners after the completion of a marathon race (42.2 km), as well as of the determinants of these changes.
- Conditions
- Athletes Heart
- Being tested
- Body fat measurement, Cardiopulmonary exercise testing, Echocardiography, Blood test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body fat measurementDiagnostic test
Body fat measurement using skinfolds
Cardiopulmonary exercise testingDiagnostic test
Electrocardiographic exercise testing with ergospirometer on a treadmill
EchocardiographyDiagnostic test
Transthoracic echocardiography
Blood testDiagnostic test
Blood test for measurement of haemoglobin, serum electrolytes, iron, ferritin and vitamins
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline left ventricular (LV) systolic function
Evaluation of LV ejection fraction
Measured: Evaluation of athletes within 3 weeks before the marathon running race.
Baseline LV diastolic function
Evaluation of LV filling pressures
Measured: Evaluation of athletes within 3 weeks before the marathon running race.
Baseline basal right ventricular (RV) function
Evaluation of tricuspid annular plane systolic excursion (TAPSE)
Measured: Evaluation of athletes within 3 weeks before the marathon running race.
Baseline global RV function
Evaluation of RV fractional are change (RVFAC)
Measured: Evaluation of athletes within 3 weeks before the marathon running race.
Post-exercise LV systolic function
Evaluation of LV ejection fraction
Measured: Evaluation of athletes immediately after the completion of the marathon running race.
Post-exercise LV diastolic function
Evaluation of LV filling pressures
Measured: Evaluation of athletes immediately after the completion of the marathon running race.
Post-exercise basal RV function
Evaluation of TAPSE
Measured: Evaluation of athletes immediately after the completion of the marathon running race.
Post-exercise global RV function
Evaluation of RVFAC
Measured: Evaluation of athletes immediately after the completion of the marathon running race.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start2 Feb 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 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 Athletes HeartStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Kouidi, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738877
- Sponsor's protocol ID
- EC-3/2020
- Acronym
- FEIDIPIDIS
- Status last verified
- Nov 2023
- First submitted
- 27 Jan 2021
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Christou GA, Pagourelias ED, Deligiannis AP, Kouidi EJ. Exploring the Anthropometric, Cardiorespiratory, and Haematological Determinants of Marathon Performance. Front Physiol. 2021 Sep 3;12:693733. doi: 10.3389/fphys.2021.693733. eCollection 2021.
PubMed 34539429
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEIDIPIDIS Study: Cardiovascular Effects of Marathon Running
- ClinicalTrials.gov ID
- NCT04738877
- Acronym / sponsor ID
- FEIDIPIDIS / EC-3/2020
- Conditions
- Athletes Heart
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 4 Feb 2021 (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.
The aim of this study is the investigation of acute cardiovascular responses of marathon runners after the completion of a marathon race (42.2 km), as well as of the determinants of these changes.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Marathon runners aiming to paricipate in a marathon running race
Key inclusion criteria (1 listed)
- Marathon runner
Key exclusion criteria (1 listed)
- Chronic disease, Drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body fat measurementBody fat measurement using skinfolds | Diagnostic test | – |
| Cardiopulmonary exercise testingElectrocardiographic exercise testing with ergospirometer on a treadmill | Diagnostic test | – |
| EchocardiographyTransthoracic echocardiography | Diagnostic test | – |
| Blood testBlood test for measurement of haemoglobin, serum electrolytes, iron, ferritin and vitamins | Diagnostic test | – |
Primary outcome
Baseline left ventricular (LV) systolic function
Time frame: Evaluation of athletes within 3 weeks before the marathon running race.
Evaluation of LV ejection fraction
Baseline LV diastolic function
Time frame: Evaluation of athletes within 3 weeks before the marathon running race.
Evaluation of LV filling pressures
Baseline basal right ventricular (RV) function
Time frame: Evaluation of athletes within 3 weeks before the marathon running race.
Evaluation of tricuspid annular plane systolic excursion (TAPSE)
Baseline global RV function
Time frame: Evaluation of athletes within 3 weeks before the marathon running race.
Evaluation of RV fractional are change (RVFAC)
Post-exercise LV systolic function
Time frame: Evaluation of athletes immediately after the completion of the marathon running race.
Evaluation of LV ejection fraction
Post-exercise LV diastolic function
Time frame: Evaluation of athletes immediately after the completion of the marathon running race.
Evaluation of LV filling pressures
Post-exercise basal RV function
Time frame: Evaluation of athletes immediately after the completion of the marathon running race.
Evaluation of TAPSE
Post-exercise global RV function
Time frame: Evaluation of athletes immediately after the completion of the marathon running race.
Evaluation of RVFAC
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 15 Nov 2023.
- Derived from this study: PubMed 34539429Christou GA, Pagourelias ED, Deligiannis AP, Kouidi EJ. Exploring the Anthropometric, Cardiorespiratory, and Haematological Determinants of Marathon Performance. Front Physiol. 2021 Sep 3;12:693733. doi: 10.3389/fphys.2021.693733. eCollection 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Athletes Heart, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 1 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 15 Nov 2023. 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 Greece. 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?
Baseline left ventricular (LV) systolic function (time frame: Evaluation of athletes within 3 weeks before the marathon running race.). The study lists 8 primary outcomes in all. 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 NCT04738877, 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 15 Nov 2023.