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CompletedNCT03356301CoATriUpdated Feb 11, 2020

Study of the Aorta Adaptations to Exercise in Triathletes During Sports Season (CoATri)

An interventional study of Cardiac MRI and Applanation tonometry in Stiffness, Aortic, Cardiac Remodeling, Ventricular and Vascular Remodeling, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to male participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Non-randomized
Ages
18 Years to 39 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Stiffness, Aortic
  • Cardiac Remodeling, Ventricular
  • Vascular Remodeling
  • Magnetic Resonance Imaging, Functional
  • Athletes

Keywords

  • Aortic compliance
  • Aortic distensibility
  • CMR
  • Triathletes
  • Ventriculo-atrial coupling
03

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Triathletes

    Every triathlete will realize three cardiac MRI exams.The second of those will be done at the fitness peak, 2-3 weeks before the main objective of the sports season. Training will be increased between the study beginning and the first MRI, and the second exam. After each cardiac MRI, an applanation tonometry examination will aslo be performed.

    Device: Cardiac MRI · Device: Applanation tonometry

  • Experimental
    Controls

    Every control subject will also realize three cardiac MRI exams if possible at the same time as the triathletes.They must be not engaged in physical activity more than 150 minutes a week on average. After each cardiac MRI, an applanation tonometry examination will aslo be performed.

    Device: Cardiac MRI · Device: Applanation tonometry

Interventions

  • DeviceCardiac MRI

    Non injected cardiac MRI exam

  • DeviceApplanation tonometry

    Applanation tonometry and ECG

05

What researchers measure

Primary outcomes

  1. Aortic compliance in triathletes in mm2/mmHG

    aortic compliance = pulsed pressure-to-absolute variation of aortic surface ratio

    Time frame: at baseline, at the fitness peak (6 to 10 months later) and at recovery (3 to 6 months after the fitness peak)

06

Study locations

1 site
  • Central Hospital
    Nancy, 54000, France
07

References and documents

Publications

  • 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. PubMed 27838232 ↗
08

Registry details

Key details

Study ID
NCT03356301
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Nov 29, 2017
Start date
Dec 1, 2017
Primary completion
Mar 8, 2019
Completion
Mar 8, 2019
Last update
Feb 11, 2020

Study contacts

Damien MANDRY, MD,PhD
principal investigator · CHRU de Nancy
Anne-Charlotte DUPONT, MD
principal investigator · CHRU de Nancy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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