Cardiovascular Consequences in Intense and Extended Physical Exercise (NCT03972865) | Clinical Trial Compass
CompletedNot Applicable
Cardiovascular Consequences in Intense and Extended Physical Exercise
France72 participantsStarted 2019-08-14
Plain-language 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.
Who can participate
Age range
20 Years – 54 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Test correlation between functional of RV changes after the race and apparition of VEB
Timeframe: 2 or 1 day(s) before the race and 3 days after