Condition or disease | Intervention/treatment | Phase |
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Ventricular Arrythmia Right Ventricular Dysfunction | Other: EmbrunMan race | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 72 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Cardiovascular Consequences and Risk of Ventricular Rhythm Disorder in Intense and Extended Physical Exercise |
Estimated Study Start Date : | August 13, 2019 |
Estimated Primary Completion Date : | August 20, 2019 |
Estimated Study Completion Date : | August 20, 2019 |
Arm | Intervention/treatment |
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Experimental: Participants of the race
Participants of the race are healthy triathlete volunteers who will participate in August 2019 in the Embrun (EmbrunMan) long-distance triathlon (Ironman)
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Other: EmbrunMan race
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.
|
Test the existence of a correlation between:
Test the existence of a correlation between:
Ages Eligible for Study: | 20 Years to 54 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christophe Hédon, MD | 0033788014630 | c-hedon@chu-montpellier.fr |
France | |
Arnaud de Villeneuve, CHU | |
Montpellier, Hérault, France, 34090 | |
Contact: Christophe Hédno, MD 0033788014630 c-hedon@chu-montpellier.fr |
Principal Investigator: | Christophe Hédon, MD | Montpellier University and Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | May 31, 2019 | ||||
First Posted Date ICMJE | June 4, 2019 | ||||
Last Update Posted Date | June 4, 2019 | ||||
Estimated Study Start Date ICMJE | August 13, 2019 | ||||
Estimated Primary Completion Date | August 20, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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:
|
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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 ] Test the existence of a correlation between:
|
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Cardiovascular Consequences in Intense and Extended Physical Exercise | ||||
Official Title ICMJE | Cardiovascular Consequences and Risk of Ventricular Rhythm Disorder in Intense and Extended Physical Exercise | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Other: EmbrunMan race
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.
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Study Arms ICMJE | Experimental: Participants of the race
Participants of the race are healthy triathlete volunteers who will participate in August 2019 in the Embrun (EmbrunMan) long-distance triathlon (Ironman)
Intervention: Other: EmbrunMan race
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
72 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 20, 2019 | ||||
Estimated Primary Completion Date | August 20, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 54 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03972865 | ||||
Other Study ID Numbers ICMJE | 5600 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | University Hospital, Montpellier | ||||
Study Sponsor ICMJE | University Hospital, Montpellier | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University Hospital, Montpellier | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |