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Intracardiac Flow Remodeling in Athletes (INFINITE)

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ClinicalTrials.gov Identifier: NCT03076788
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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.

Condition or disease Intervention/treatment
Cardiac Remodeling, Ventricular Other: electrocardiogram and echocardiography

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intracardiac Flow Remodeling in Athletes
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

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.




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Athletes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076788


Locations
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France
CHU de CAEN
Caen, Normandie, France, 14000
Sponsors and Collaborators
University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03076788     History of Changes
Other Study ID Numbers: 16-022.
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Caen:
echocardiography
intraventricular pressure gradients
cardiac remodeling
athletes
Additional relevant MeSH terms:
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Ventricular Remodeling
Pathological Conditions, Anatomical