INFINITE: Intracardiac Flow Remodeling in Athletes

Sponsor

University Hospital, Caen (Other)

Overall Status

Completed

CT.gov ID

NCT03076788

Collaborator

(none)

100

Enrollment

Location

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Cardiac Remodeling, Ventricular	Other: electrocardiogram and echocardiography

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Intracardiac Flow Remodeling in Athletes

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

Evaluation of ventricular response to exercise training by echocardiography. [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 Outcome Measures

Evaluation of ventricular response to exercise training by electrocardiogram [Day 1]
heart rate (bpm), ventricular hypertrophy (mV) atrial remodeling (mV)
Sport and medical history questionnaire [Day 1]
exercise training program, medical past history, cardiovascular risk factors, treatments, doping.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de CAEN	Caen	Normandie	France	14000

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT03076788

Other Study ID Numbers:

16-022.

First Posted:

Mar 10, 2017

Last Update Posted:

Aug 6, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by University Hospital, Caen

echocardiography

intraventricular pressure gradients

cardiac remodeling

athletes

Additional relevant MeSH terms:

Ventricular Remodeling

Study Results

No Results Posted as of Aug 6, 2019