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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03356301
Other study ID # 2017-A01872-51
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date March 8, 2019

Study information

Verified date January 2019
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Regular sustained physical activity creates a cardiac remodelling : it is athlete's heart. In our preliminary work published in 2016, the investigators demonstrated in a small population of triathletes that there is also a vascular remodelling named athlete's artery. Moreover, the investigators know that left ventricle and aorta behave together like a couple. So they want to study by Cardiovascular Magnetic Resonance Imaging the impact of triathlon on the cardiac AND aortic remodelling.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date March 8, 2019
Est. primary completion date March 8, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria:

- to be enrolled in a social security plan.

- to have a BMI between 18,5 and 25 kg/m²

- to have received full information on the organization of the research and having signed its informed consent

- to have carried out a clinical screening adapted to the research

*** Triathlete group:

- to have a minimum performance level: between 2h and 2h45 on an M triathlon during the past year (provide proof),

- to participate in 2018 in a long distance triathlon, i. e. at least distance L

- to have a defined training volume: less than 8 hours per week during the winter months and between 10 and 15 hours per week in preparation of the objective

***Control group:

- to have no more than 150 minutes of moderate physical activity per week (footing, brisk walking, cycling, etc.).

Exclusion Criteria:

- Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code

- Cardiovascular history including Ii.e. known heart rhythm disorders

- Chronic disease: diabetes, high blood pressure...

- Long-term drug therapies that may modify cardiovascular remodeling such as Conversion Enzyme Inhibitor, Angiotensin II Receptor Antagonist,

- Active smoking, even if occasional

- Contraindication to MRI

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Cardiac MRI
Non injected cardiac MRI exam
Applanation tonometry
Applanation tonometry and ECG

Locations

Country Name City State
France Central Hospital Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Dupont AC, Poussel M, Hossu G, Marie PY, Chenuel B, Felblinger J, Mandry D. Aortic compliance variation in long male distance triathletes: A new insight into the athlete's artery? J Sci Med Sport. 2017 Jun;20(6):539-542. doi: 10.1016/j.jsams.2016.10.009. Epub 2016 Oct 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Aortic compliance in triathletes in mm2/mmHG aortic compliance = pulsed pressure-to-absolute variation of aortic surface ratio at baseline, at the fitness peak (6 to 10 months later) and at recovery (3 to 6 months after the fitness peak)
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