Doppler EchocardiographyEUROFILLINGNCT02883504
Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure
A study testing Echo-Doppler examination and left heart catheterization in people with Doppler Echocardiography, run by Rennes University Hospital at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Doppler Echocardiography
- What is being tested?
- Echo-Doppler examination and left heart catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Patient performing an echocardiography in the routine clinical practice
- Informed consent given
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Doppler Echocardiography
- Being tested
- Echo-Doppler examination and left heart catheterization
- Keywords
- E/e' ratio, Doppler echocardiography, filling pressure, Left Ventricular end-Diastolic Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo-Doppler examination and left heart catheterizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Echocardiography | Experimental | Not described Receives: Procedure: Echo-Doppler examination and left heart catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive evaluation of left ventricular end diastolic pressure
Left heart catheterization
Measured: D0
Secondary outcomes (1)
Non-invasive evaluation of left ventricular end diastolic pressure
Echo-Doppler
Measured: D0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startNov 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Doppler EchocardiographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwan Donal, Md, PhD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883504
- Sponsor's protocol ID
- 2014-A01331-46
- Other IDs
- 35RC14_3003
- Acronym
- EUROFILLING
- Status last verified
- Jun 2026
- First submitted
- 22 Aug 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure
- ClinicalTrials.gov ID
- NCT02883504
- Acronym / sponsor ID
- EUROFILLING / 2014-A01331-46
- Conditions
- Doppler Echocardiography
- Keywords
- E/e' ratio, Doppler echocardiography, filling pressure, Left Ventricular end-Diastolic Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echocardiography | Experimental | Procedure: Echo-Doppler examination and left heart catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years
- Patient performing an echocardiography in the routine clinical practice
- Informed consent given
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echo-Doppler examination and left heart catheterization | Procedure or surgery | Echocardiography |
Primary outcome
Invasive evaluation of left ventricular end diastolic pressure
Time frame: D0
Left heart catheterization
1 secondary outcome
Non-invasive evaluation of left ventricular end diastolic pressure
Time frame: D0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwan Donal, Md, PhD study director
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echo-Doppler examination and left heart catheterization in people with Doppler Echocardiography, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive evaluation of left ventricular end diastolic pressure (time frame: D0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.