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

NCT ID: NCT02883504

Last Updated: 2016-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Doppler Echocardiography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Echocardiography

Group Type EXPERIMENTAL

Echo-Doppler examination and left heart catheterization

Intervention Type PROCEDURE

Interventions

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Echo-Doppler examination and left heart catheterization

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erwan Donal, Md, PhD

Role: STUDY_DIRECTOR

CHU Rennes

Locations

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CHU Rennes

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC14_3003

Identifier Type: OTHER

Identifier Source: secondary_id

2014-A01331-46

Identifier Type: -

Identifier Source: org_study_id

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