Validation Study of the Accuracy of E/e' in Estimating Le... | NCT02883504

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

NCT02883504

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Jun 12, 2026Actual

Enrollment

85Actual

Phase

Not Applicable

Conditions

Doppler Echocardiography

Interventions

Echo-Doppler examination and left heart catheterization

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
35RC14_3003	Other Identifier	CHU Rennes

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014Actual

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Aug 22, 2016

First Submission Date that Met QC Criteria

Aug 24, 2016

First Posted Date

Aug 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 12, 2026Actual

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Echocardiography	Experimental		Procedure: Echo-Doppler examination and left heart catheterization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Echo-Doppler examination and left heart catheterization	Procedure		Echocardiography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Invasive evaluation of left ventricular end diastolic pressure	Left heart catheterization	D0

Secondary Outcomes

Measure	Description	Time Frame
Non-invasive evaluation of left ventricular end diastolic pressure	Echo-Doppler	D0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erwan Donal, Md, PhD	Rennes University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Rennes		Rennes			France