Cardiovascular Consequences in Intense and Extended Physical Exercise

NCT03972865 | Completed DMC

• 2 other identifiers: RECHMPL17_03852018-A00237-48
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Arrythmia; Right Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  2 or 1 day(s) before the race and 3 days after

Study Arms (1)

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)

Other: EmbrunMan race

Interventions

EmbrunMan race OTHER

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.

Participants of the race

Eligibility Criteria

• Age: 20 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Arnaud de Villeneuve, CHU

Montpellier, Hérault, 34090, France

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Christophe Hédon, MD

  Montpellier University and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 4, 2019
• Study Start: August 14, 2019
• Primary Completion: August 21, 2019
• Study Completion: March 1, 2021
• Last Updated: September 30, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)