NCT03076788

Brief Summary

The uncertainty concerning the onset and the extent of cardiac remodeling in response to intensive training hinders medical evaluation by physician. A better knowledge of the physiology of cardiac adaptation to training will enable physicians to correctly determine whether observed patterns of cardiac remodeling are physiological or pathological. This prospective study proposes to assess in a trained-athlete population the cardiac remodeling in response to intensive exercise training. This study is observational, we do not interfere with athlete's training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

February 16, 2017

Last Update Submit

February 11, 2024

Conditions

Keywords

echocardiographyintraventricular pressure gradientscardiac remodelingathletes

Outcome Measures

Primary Outcomes (1)

  • Evaluation of ventricular response to exercise training by echocardiography.

    1. 2D- morphological and functional parameters of both left and right ventricles: * end-diastolic and end-systolic dimensions (cm) * left ventricular mass (g) * ventricular end-diastolic and end-systolic areas (cm²) * ventricular ejection fraction (%) * atrial volumes (ml) * diastolic indices by pulsed wave Doppler and tissue Doppler (cm/s) * myocardial deformation by speckle tracking (%) 2. 3D- morphological and functional parameters of both left and right ventricles: * ventricular full volumes (ml) * ejection fraction (%) 3. Intracardiac flow measurements by color Doppler M-mode: estimation of intra ventricular pressure gradients between the base and the apex (mmHg).

    Day 1

Secondary Outcomes (2)

  • Evaluation of ventricular response to exercise training by electrocardiogram

    Day 1

  • Sport and medical history questionnaire

    Day 1

Study Arms (2)

Athletes

Professional and amateur athletes examined during the medical follow-up at the medical sport centre of Caen University Hospital. The medical examination consists in a clinical exam, an electrocardiogram and an echocardiography.

Other: electrocardiogram and echocardiography

Sedentary controls

Sedentary patients assessed in the cardiology unit with a normal heart function. The medical examination consists in a clinical exam, an electrocardiogram and an echocardiography.

Other: electrocardiogram and echocardiography

Interventions

We retrieved all electrocardiograms and echocardiography made during the clinical examination of each athlete and each sedentary control. * Standard 12 lead ECG * Trans-thoracic echocardiography examination of cardiac function, morphology and intracardiac flow.

AthletesSedentary controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Athletes

You may qualify if:

  • Age \> 18yrs old
  • Ability to give written consent for participating in the study

You may not qualify if:

  • Age \< 18yrs old
  • Cardiac diseases, arterial hypertension, cardiac devices, diabetes, renal, liver or pulmonary failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de CAEN

Caen, Normandy, 14000, France

Location

MeSH Terms

Conditions

Ventricular Remodeling

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 16, 2017

First Posted

March 10, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations