Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure

Doppler Echocardiography Clinical Trial

— EUROFILLING  

Official title:

Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883504
• Other study ID #: 2014-A01331-46
• Secondary ID: 35RC14_3003
• Status: Completed
• Phase: N/A
• First received: August 22, 2016
• Last updated: September 5, 2016
• Start date: November 2014

Study information

• Verified date: August 2016
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial Summary

The non-invasive estimation of left ventricular end diastolic pressure (LVeDP) is a main goal for performing an echocardiography in the routine clinical practice. Conflicting evidence exists about mitral E/e' ratio reliability for predicting high LVeDP

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years

• Patient performing an echocardiography in the routine clinical practice

• Informed consent given

Exclusion Criteria:

• Severe valve disease, valvular prostheses, calcification of the mitral valve, the history of myocardial infarction, atrial fibrillation, severe arrhythmias not allowing the Doppler analysis, pacemaker and any image by inadequate Doppler ultrasound

• Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Doppler Echocardiography

Intervention

Procedure:
• Echo-Doppler examination and left heart catheterization

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive evaluation of left ventricular end diastolic pressure	Left heart catheterization	D0	No
Secondary	Non-invasive evaluation of left ventricular end diastolic pressure	Echo-Doppler	D0	No