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OpenTrials
Completed

NCT Number: NCT03076788

Intracardiac Flow Remodeling in Athletes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de CAEN

Caen, Normandy, 14000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electrocardiogram and echocardiography

Other

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.

Primary outcomes

  1. Evaluation of ventricular response to exercise training by echocardiography.

    Time frame: Day 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 (%)
    • 3D- morphological and functional parameters of both left and right ventricles:
    • ventricular full volumes (ml)
    • ejection fraction (%)
    • Intracardiac flow measurements by color Doppler M-mode:

    estimation of intra ventricular pressure gradients between the base and the apex (mmHg).

Secondary outcomes

  1. Evaluation of ventricular response to exercise training by electrocardiogram

    Time frame: Day 1

    • heart rate (bpm),
    • ventricular hypertrophy (mV)
    • atrial remodeling (mV)
  2. Sport and medical history questionnaire

    Time frame: Day 1

    exercise training program, medical past history, cardiovascular risk factors, treatments, doping.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: INFINITE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2017
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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