Intracardiac Flow Remodeling in Athletes (INFINITE)

February 11, 2024 updated by: Amir HODZIC, University Hospital, Caen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Normandie
      • Caen, Normandie, France, 14000
        • CHU de Caen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Athletes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of ventricular response to exercise training by echocardiography.
Time Frame: Day 1

  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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of ventricular response to exercise training by electrocardiogram
Time Frame: Day 1
  • heart rate (bpm),
  • ventricular hypertrophy (mV)
  • atrial remodeling (mV)
Day 1
Sport and medical history questionnaire
Time Frame: Day 1
exercise training program, medical past history, cardiovascular risk factors, treatments, doping.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-022.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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