Cardiovascular Consequences in Intense and Extended Physical Exercise (PHILIPPIDES)
Primary Purpose
Ventricular Arrythmia, Right Ventricular Dysfunction
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EmbrunMan race
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventricular Arrythmia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Arnaud de Villeneuve, CHU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants of the race
Arm Description
Participants of the race are healthy triathlete volunteers who will participate in August 2019 in the Embrun (EmbrunMan) long-distance triathlon (Ironman)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03972865
First Posted
May 31, 2019
Last Updated
January 12, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03972865
Brief Title
Cardiovascular Consequences in Intense and Extended Physical Exercise
Acronym
PHILIPPIDES
Official Title
Cardiovascular Consequences and Risk of Ventricular Rhythm Disorder in Intense and Extended Physical Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
August 21, 2019 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrythmia, Right Ventricular Dysfunction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants of the race
Arm Type
Experimental
Arm Description
Participants of the race are healthy triathlete volunteers who will participate in August 2019 in the Embrun (EmbrunMan) long-distance triathlon (Ironman)
Intervention Type
Other
Intervention Name(s)
EmbrunMan race
Intervention Description
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.
Primary Outcome Measure Information:
Title
Test correlation between functional of RV changes after the race and apparition of VEB
Description
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.
Time Frame
2 or 1 day(s) before the race and 3 days after
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
2 or 1 day(s) before the race and 3 days after
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Hédon, MD
Organizational Affiliation
Montpellier University and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arnaud de Villeneuve, CHU
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34090
Country
France
12. IPD Sharing Statement
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Cardiovascular Consequences in Intense and Extended Physical Exercise
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