NCT02883504

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

September 7, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

August 22, 2016

Last Update Submit

September 5, 2016

Conditions

Doppler Echocardiography

Keywords

E/e' ratioDoppler echocardiography, filling pressureLeft Ventricular end-Diastolic Pressure

Outcome Measures

Primary Outcomes (1)

  • Invasive evaluation of left ventricular end diastolic pressure

    Left heart catheterization

    D0

Secondary Outcomes (1)

  • Non-invasive evaluation of left ventricular end diastolic pressure

    D0

Study Arms (1)

Echocardiography

EXPERIMENTAL
Procedure: Echo-Doppler examination and left heart catheterization

Interventions

Echo-Doppler examination and left heart catheterizationPROCEDURE
Echocardiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • Patient performing an echocardiography in the routine clinical practice
  • Informed consent given

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, France

Location

Study Officials

  • Erwan Donal, Md, PhD

    CHU Rennes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 30, 2016

Study Start

November 1, 2014

Primary Completion

August 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-08

Locations

FR(1)