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CompletedNCT03076788INFINITEUpdated Feb 13, 2024

Intracardiac Flow Remodeling in Athletes

An observational study in Cardiac Remodeling, Ventricular, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by University Hospital, Caen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Remodeling, Ventricular

Keywords

  • echocardiography
  • intraventricular pressure gradients
  • cardiac remodeling
  • athletes
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In context

Ventricular Remodeling

105 studies on the registry are indexed under Ventricular Remodeling; 24 are open to participants now.

This study's enrollment of 100 is below the median of 180 across 32 observational studies indexed under Ventricular Remodeling.

Browse Ventricular Remodeling studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Athletes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Otherelectrocardiogram 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.

06

What researchers measure

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).

    Time frame: Day 1

Secondary outcomes

  1. Evaluation of ventricular response to exercise training by electrocardiogram

    * heart rate (bpm), * ventricular hypertrophy (mV) * atrial remodeling (mV)

    Time frame: Day 1

  2. Sport and medical history questionnaire

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

    Time frame: Day 1

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Study locations

1 site
  • CHU de CAEN
    Caen, Normandie 14000, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03076788
Responsible party
Amir HODZIC (Medical Doctor, University Hospital, Caen) — Principal investigator
First posted
Mar 10, 2017
Start date
Jan 1, 2017
Primary completion
Jan 1, 2019
Completion
Jan 1, 2019
Last update
Feb 13, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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