Intracardiac Flow Remodeling in Athletes

Cardiac Remodeling, Ventricular Clinical Trial

— INFINITE  

Official title:

Intracardiac Flow Remodeling in Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076788
• Other study ID #: 16-022.
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: February 2024
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Remodeling, Ventricular
• Ventricular Remodeling

Intervention

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.

Locations

Country	Name	City	State
France	CHU de CAEN	Caen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of ventricular response to exercise training by echocardiography.	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).	Day 1
Secondary	Evaluation of ventricular response to exercise training by electrocardiogram	heart rate (bpm),; ventricular hypertrophy (mV); atrial remodeling (mV)	Day 1
Secondary	Sport and medical history questionnaire	exercise training program, medical past history, cardiovascular risk factors, treatments, doping.	Day 1