NCT03356301

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2019

Completed
Last Updated

February 11, 2020

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

November 22, 2017

Last Update Submit

February 10, 2020

Conditions

Stiffness, AorticCardiac Remodeling, VentricularVascular RemodelingMagnetic Resonance Imaging, FunctionalAthletes

Keywords

Aortic complianceAortic distensibilityCMRTriathletesVentriculo-atrial coupling

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Triathletes

EXPERIMENTAL

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 MRIDevice: Applanation tonometry

Controls

EXPERIMENTAL

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 MRIDevice: Applanation tonometry

Interventions

Cardiac MRIDEVICE

Non injected cardiac MRI exam

ControlsTriathletes
Applanation tonometryDEVICE

Applanation tonometry and ECG

ControlsTriathletes

Eligibility Criteria

Age18 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital

Nancy, 54000, France

Location

Related 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.

    PMID: 27838232BACKGROUND

MeSH Terms

Conditions

Ventricular RemodelingVascular Remodeling

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Damien MANDRY, MD,PhD

    CHRU de Nancy

    PRINCIPAL INVESTIGATOR

  • Anne-Charlotte DUPONT, MD

    CHRU de Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2017

First Posted

November 29, 2017

Study Start

December 1, 2017

Primary Completion

March 8, 2019

Study Completion

March 8, 2019

Last Updated

February 11, 2020

Record last verified: 2019-01

Locations

FR(1)