Ventricular ArrythmiaPHILIPPIDESNCT03972865
Cardiovascular Consequences in Intense and Extended Physical Exercise
A study testing EmbrunMan race in people with Ventricular Arrythmia and Right Ventricular Dysfunction, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This research study because you participate in long distance triathlon of Embrun. In recent years, there has been a craze for races at increasingly longer distances (ultra-endurance) with risks to the cardiovascular system poorly identified. Read more about this study
- Who is it for?
- Ages 20 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ventricular Arrythmia, Right Ventricular Dysfunction
- What is being tested?
- EmbrunMan race
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 14 Aug 2019to 1 Mar 2021
- Phase
- Interventional
- 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 20 to 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male sex
- Age between 20 to 54 years old
- Participating in the triathlon of Embrun 2019
- Collection of free and informed consent given verbally and in writing.
Who cannot join
- History of heart disease
- History of cardiac rhythm disorder.
- Subject with 1 or more cardiovascular risk factors (tobacco, diabetes, hypertension, BMI> 30).
- Cardiac, vascular or respiratory treatment(s).
- Use of substances on the list of doping products of the French Anti-Doping Agency (https://www.afld.fr/wp-content/uploads/2018/01/Liste-des- prohibitions-2018.pdf)
- Subject in relative exclusion period compared to another protocol or for which the annual amount of the maximum indemnities of 4500 € has been reached.
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- Participation of the subject in another study
- Subject not affiliated to a social security scheme, or not a beneficiary of such a scheme.
- Pregnant or nursing woman, patient unable to give her protected primary consent, vulnerable persons (art.L.1121-6, L.1121-7, L.1211-8, L.1211-9)
- Subject deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Consequences and Risk of Ventricular Rhythm Disorder in Intense and Extended Physical Exercise
This research study because you participate in long distance triathlon of Embrun. In recent years, there has been a craze for races at increasingly longer distances (ultra-endurance) with risks to the cardiovascular system poorly identified. In the short term, cardiac functional ultrasonographic changes and disturbances of biomarkers such as troponin are reported in participants in long-term endurance trials, assuming myocardial remodeling and transient tissue damage leading to suffering or "heart fatigue". These constraints could, to the extreme, favor the development of arrhythmia at the atrial and ventricular stages. Cardiac alterations are nevertheless poorly characterized and the consequences, in particular the risk of ventricular rhythm disturbance, have not been studied.The aim of this study is to investigate the relationship between right ventricular functional abnormalities and the occurrence of ventricular rhythm disturbance, following intense and prolonged exercise, in healthy triathletes subjects.
Read the detailed description
Background and rationale:
While regular and moderate physical activity is strongly recommended in reducing cardiovascular risk, the scientific community questions the potentially harmful effects of prolonged and intense physical activity. In the short term, functional ultrasonographic changes (systolic and diastolic) and disturbances of biomarkers such as troponin are reported in participants in long-term endurance trials, assuming myocardial remodeling and transient tissue damage leading to suffering or "heart fatigue". These constraints could, to the extreme, favor the development of arrhythmogenic foci at the atrial and ventricular stages, and at least, be responsible for a sudden death of the athlete. Adaptations of the athlete's heart have mainly been studied in the left ventricle but more and more studies are studying the right ventricle (RV). These alterations are nevertheless poorly characterized and the consequences including the risk of ventricular rhythm disorder have not been studied.
Primary and Secondary Objectives:
The primary objective is to test the existence of a relationship between RV functional abnormalities induced by intense and prolonged exercise, and the occurrence of ventricular ectopic beats (VEB) from RV. The secondary objectives are to characterize the respiratory impairment of this type of course and to study its relation with the functional anomalies of the RV and the occurrence of VEB.
Methodology:
This is a prospective study including male triathletes participating in the long-distance triathlon of Embrun in August 2019 (3.8 km of swimming, 188 km of cycling and 42.2 km of running), aged between 20 to 54 years years old. The criteria for non-inclusion are subjects with a history of heart disease or rhythm disorder or who have one or more cardiovascular risk factors, taking cardiovascular treatment or using doping products. The primary endpoint is the degree of correlation between course induced right ventricular functional abnormalities (by the use of 2d-strain ultrasound imaging) and the number of VEB from RV during or up to 72 hours after the race.
Procedure:
The study will take place during the Embrun triathlon in August 2019. There will be 2 evaluations: one before the race and one 30 minutes after the race, where will be carried out a self-questionnaire, a clinical examination, EKG, echocardiography and spirometry. An EKG holter in the form of a patch, adapted to sport and submersible practice, will be put in place 24 to 48 hours before the race and left until 72 hours after the race.
Outcomes / perspectives:
Characterizing the effects of a long-distance triathlon on cardiac contractile function and evaluating the athlete's rhythmic risk would make it possible to better understand these pathophysiological consequences and ultimately better detect athletes at risk of sudden death.
- Being tested
- EmbrunMan race
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbrunMan raceOther
The EmbrunMan is a long-duration triathlon including 3.8 km of swimming, 188 km of cycling and 42.2 km of running, with a cumulative vertical drop of 4000 metres. Duration of the race varies between 10 hours and 16hours depending on the athletes' performance.
| Study group | Role | What they receive |
|---|---|---|
| Participants of the race | Experimental | Participants of the race are healthy triathlete volunteers who will participate in August 2019 in the Embrun (EmbrunMan) long-distance triathlon (Ironman) Receives: Other: EmbrunMan race |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test correlation between functional of RV changes after the race and apparition of VEB
Test the existence of a correlation between:
- the right ventricular functional changes observed immediately following an intense and prolonged exercise, evaluated by echocardiography and the "2d-strain" longitudinal deformation imaging technique, by performing the examination just after the race and by comparing it with before race : the main endpoint considered will be the value of the systolic peak of global longitudinal deformation (mean of the 3 segments of the free wall of the right ventricle),
- and the number of VEB / 30 minutes from the right ventricle, quantified by an ECG holter worn during the race and up to 72 hours after the race.
Measured: 2 or 1 day(s) before the race and 3 days after
Secondary outcomes (1)
The secondary objectives are to characterize the respiratory impairment of this type of course and to study its relation with the functional anomalies of the RV and the occurrence of VEB.
Test the existence of a correlation between:
- modification of the respiratory function (Forced expiratory volume, Carbon Monoxide gaz transfer) in comparison with after and before the race
- and right ventricular functional changes, evaluated by echocardiography and the "2d-strain" longitudinal deformation imaging technique (value of the systolic peak of global longitudinal deformation (mean of the 3 segments of the free wall of the right ventricle) and the occurrence of VEB
Measured: 2 or 1 day(s) before the race and 3 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start14 Aug 2019
- Primary completion21 Aug 2019
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Hédon, MD, Principal investigator, Montpellier University and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972865
- Sponsor's protocol ID
- RECHMPL17_0385
- Other IDs
- 2018-A00237-48
- Acronym
- PHILIPPIDES
- Status last verified
- Jan 2022
- First submitted
- 31 May 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Consequences and Risk of Ventricular Rhythm Disorder in Intense and Extended Physical Exercise
- ClinicalTrials.gov ID
- NCT03972865
- Acronym / sponsor ID
- PHILIPPIDES / RECHMPL17_0385
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 4 Jun 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.
This research study because you participate in long distance triathlon of Embrun. In recent years, there has been a craze for races at increasingly longer distances (ultra-endurance) with risks to the cardiovascular system poorly identified. In the short term, cardiac functional ultrasonographic changes and disturbances of biomarkers such as troponin are reported in participants in long-term endurance trials, assuming myocardial remodeling and transient tissue damage leading to suffering or "heart fatigue". These constraints could, to the extreme, favor the development of arrhythmia at the atrial and ventricular stages. Cardiac alterations are nevertheless poorly characterized and the consequences, in particular the risk of ventricular rhythm disturbance, have not been studied.The aim of this study is to investigate the relationship between right ventricular functional abnormalities and the occurrence of ventricular rhythm disturbance, following intense and prolonged exercise, in healthy triathletes subjects.
Detailed description
Background and rationale:
While regular and moderate physical activity is strongly recommended in reducing cardiovascular risk, the scientific community questions the potentially harmful effects of prolonged and intense physical activity. In the short term, functional ultrasonographic changes (systolic and diastolic) and disturbances of biomarkers such as troponin are reported in participants in long-term endurance trials, assuming myocardial remodeling and transient tissue damage leading to suffering or "heart fatigue". These constraints could, to the extreme, favor the development of arrhythmogenic foci at the atrial and ventricular stages, and at least, be responsible for a sudden death of the athlete. Adaptations of the athlete's heart have mainly been studied in the left ventricle but more and more studies are studying the right ventricle (RV). These alterations are nevertheless poorly characterized and the consequences including the risk of ventricular rhythm disorder have not been studied.
Primary and Secondary Objectives:
The primary objective is to test the existence of a relationship between RV functional abnormalities induced by intense and prolonged exercise, and the occurrence of ventricular ectopic beats (VEB) from RV. The secondary objectives are to characterize the respiratory impairment of this type of course and to study its relation with the functional anomalies of the RV and the occurrence of VEB.
Methodology:
This is a prospective study including male triathletes participating in the long-distance triathlon of Embrun in August 2019 (3.8 km of swimming, 188 km of cycling and 42.2 km of running), aged between 20 to 54 years years old. The criteria for non-inclusion are subjects with a history of heart disease or rhythm disorder or who have one or more cardiovascular risk factors, taking cardiovascular treatment or using doping products. The primary endpoint is the degree of correlation between course induced right ventricular functional abnormalities (by the use of 2d-strain ultrasound imaging) and the number of VEB from RV during or up to 72 hours after the race.
Procedure:
The study will take place during the Embrun triathlon in August 2019. There will be 2 evaluations: one before the race and one 30 minutes after the race, where will be carried out a self-questionnaire, a clinical examination, EKG, echocardiography and spirometry. An EKG holter in the form of a patch, adapted to sport and submersible practice, will be put in place 24 to 48 hours before the race and left until 72 hours after the race.
Outcomes / perspectives:
Characterizing the effects of a long-distance triathlon on cardiac contractile function and evaluating the athlete's rhythmic risk would make it possible to better understand these pathophysiological consequences and ultimately better detect athletes at risk of sudden death.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants of the race | Experimental | Other: EmbrunMan raceParticipants of the race are healthy triathlete volunteers who will participate in August 2019 in the Embrun (EmbrunMan) long-distance triathlon (Ironman) |
Who may qualify
- Ages
- 20 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male sex
- Age between 20 to 54 years old
- Participating in the triathlon of Embrun 2019
- Collection of free and informed consent given verbally and in writing.
Key exclusion criteria (10 listed)
- History of heart disease
- History of cardiac rhythm disorder.
- Subject with 1 or more cardiovascular risk factors (tobacco, diabetes, hypertension, BMI> 30).
- Cardiac, vascular or respiratory treatment(s).
- Use of substances on the list of doping products of the French Anti-Doping Agency (https://www.afld.fr/wp-content/uploads/2018/01/Liste-des- prohibitions-2018.pdf)
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 |
|---|---|---|
| EmbrunMan raceThe EmbrunMan is a long-duration triathlon including 3.8 km of swimming, 188 km of cycling and 42.2 km of running, with a cumulative vertical drop of 4000 metres. Duration of the race varies between 10 hours and 16hours depending on the athletes' performance. | Other | Participants of the race |
Primary outcome
Test correlation between functional of RV changes after the race and apparition of VEB
Time frame: 2 or 1 day(s) before the race and 3 days after
Test the existence of a correlation between: * the right ventricular functional changes observed immediately following an intense and prolonged exercise, evaluated by echocardiography and the "2d-strain" longitudinal deformation imaging technique, by performing the examination just after the race and by comparing it with before race : the main endpoint considered will be the value of the systolic peak of global longitudinal deformation (mean of the 3 segments of the free wall of the right ventricle), * and the number of VEB / 30 minutes from the right ventricle, quantified by an ECG holter worn during the race and up to 72 hours after the race.
1 secondary outcome
The secondary objectives are to characterize the respiratory impairment of this type of course and to study its relation with the functional anomalies of the RV and the occurrence of VEB.
Time frame: 2 or 1 day(s) before the race and 3 days after
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 30 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Christophe Hédon, MD principal investigator
Montpellier University and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmbrunMan race in people with Ventricular Arrythmia and Right Ventricular Dysfunction, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 10 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 30 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 France. 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?
Test correlation between functional of RV changes after the race and apparition of VEB (time frame: 2 or 1 day(s) before the race and 3 days after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025.