MoralityEPRAoVNCT03628313
Valvular Aortic Stenosis Prognosis Study
An observational study of Morality, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Aortic stenosis is the most common valvulopathy in Western countries. Cardiac EchoDoppler is the reference method for assessment of aortic stenosis and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Morality
- What is being tested?
- Transthoracic ultrasound
- How many people
- 3,450 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2015to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will be identified from the transthoracic echocardiography reports of the echocardiography laboratory of CHU Amiens and CH Saint Philibert for the retrospective part. They are prospectively identified during echocardiography performed in the echocardiography laboratory of the two participating centers when a diagnosis of aortic stenosis is made. Patients will be informed by newsletter.
Who may be able to join
- Retrospectively, all patients examined from January 1, 2000 to November 2014 will be included in the echocardiography laboratory whose objective examination is a narrowing of the aortic valve (maximum transaortic velocity ≥2.5 m / s).
- Aortic stenosis may be known in the past.
Who cannot join
- Refusal of the patient to participate in the study.
- Patients who have previously had aortic valve surgery before being examined in the echocardiography laboratory.
- Patients who can not be contacted or who do not respond will not be included in the database.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Amiens-Picardie
Amiens, France, 80000
TRIBOUILLOY CHRISTOPHE
About this study
Official title: Valvular Aortic Stenosis Prognosis Study: Prospective and Retrospective Follow-up of a Cohort of Patients With Aortic Valve Narrowing
Aortic stenosis is the most common valvulopathy in Western countries. Cardiac EchoDoppler is the reference method for assessment of aortic stenosis and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low flow and low gradient aortic retraction is discussed.
The main objective of this work is to study the prognosis of asymptomatic and symptomatic aortic retraction.
Read the detailed description
Aortic stenosis is an attack most often acquired from the aortic valve corresponding to a defect of opening of this valve. Its prevalence increases with age and approaches 2% at age 65 and 25% at age 85 . It is in the majority of cases degenerative due to the development of calcifications on the aortic sigmoid valves by a process close to atherosclerosis (Otto CM, Circulation, 1994). It is associated with cardiovascular risk factors (age, male sex, smoking, high blood pressure and associated high LDL cholesterol). Aortic stenosis may also frequently be the consequence of aortic bicuspid (congenital) or more rarely rheumatic fever.
Aortic stenosis is responsible for an obstacle to ejection of the left ventricle with increased afterload and thus left ventricular work. After a long asymptomatic period when the obstacle to ejection is compensated by the induction of an adaptive left ventricular hypertrophy, symptoms appear initially of effort (dyspnea, angina, lipothymia see syncope) then clinical signs of insufficiency heart. The occurrence of symptoms should cause aortic valve replacement because at this stage the prognosis becomes unfavorable with a risk of death by cardiac decompensation or sudden death.
The two pillars of the diagnosis of severity are the evaluation of functional aortic valve area and the average transvalvular gradient. The tight aortic stenosis is defined for a functional aortic area <1cm² or 0.6cm² / m² and a mean tranvular gradient> 40 mmHg.
Patient survival data and / or a possible complication or indication for surgery will be evaluated periodically either during a standard follow-up consultation if patients are followed in the referral center or by telephone contact with the attending physician or cardiologist. . In case of death, the cause and date will be collected.
- Conditions
- Morality
- Being tested
- Transthoracic ultrasound
- Keywords
- Echoacrdiography, EchoDoppler, Aortic valve stenosis, Prognosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic ultrasoundOther
Patients are prospectively identified during echocardiography performed in the echocardiography laboratory of the two participating centers when a diagnosis of aortic stenosis is made.
| Study group | Role | What they receive |
|---|---|---|
| Aortic valve stenosis | The participants will be identified from the Transthoracic ultrasound echocardiography reports of the echocardiography laboratory of the University Hospital of Amiens and CH Philibert for the retrospective part. They are analyzed during echocardiography at the echocardiography laboratory of two participating centers when a diagnosis of aortic stenosis is made. Patients are informed by newsletter. Receives: Other: Transthoracic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis of asymptomatic and symptomatic aortic valve stenosis
Aortic valve stenosis (Rao) is the most common valvulopathy in Western countries. Cardiac EchoDoppler represents the reference method of evaluation of Rao and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low-gradient and low-gradient Rao is discussed.) The main objective of this work is to study the prognosis of asymptomatic and symptomatic aortic valve stenosis. To Look for predictors of prognosis and To Evaluate the impact of comorbidities on the prognosis of RAo Evaluate operative indications and specify the short and long term outcome after surgery.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start3 Sep 2015
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoralityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe TRIBOUILLOY, MD, PhD, Principal investigator, CHU AMIENS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628313
- Sponsor's protocol ID
- RNI2014-16
- Acronym
- EPRAoV
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2018
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valvular Aortic Stenosis Prognosis Study: Prospective and Retrospective Follow-up of a Cohort of Patients With Aortic Valve Narrowing
- ClinicalTrials.gov ID
- NCT03628313
- Acronym / sponsor ID
- EPRAoV / RNI2014-16
- Conditions
- Morality
- Keywords
- Echoacrdiography, EchoDoppler, Aortic valve stenosis, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,450 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 3 Sep 2015 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 14 Aug 2018 (actual)
- 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.
Aortic stenosis is the most common valvulopathy in Western countries. Cardiac EchoDoppler is the reference method for assessment of aortic stenosis and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low flow and low gradient aortic retraction is discussed.
The main objective of this work is to study the prognosis of asymptomatic and symptomatic aortic retraction.
Detailed description
Aortic stenosis is an attack most often acquired from the aortic valve corresponding to a defect of opening of this valve. Its prevalence increases with age and approaches 2% at age 65 and 25% at age 85 . It is in the majority of cases degenerative due to the development of calcifications on the aortic sigmoid valves by a process close to atherosclerosis (Otto CM, Circulation, 1994). It is associated with cardiovascular risk factors (age, male sex, smoking, high blood pressure and associated high LDL cholesterol). Aortic stenosis may also frequently be the consequence of aortic bicuspid (congenital) or more rarely rheumatic fever.
Aortic stenosis is responsible for an obstacle to ejection of the left ventricle with increased afterload and thus left ventricular work. After a long asymptomatic period when the obstacle to ejection is compensated by the induction of an adaptive left ventricular hypertrophy, symptoms appear initially of effort (dyspnea, angina, lipothymia see syncope) then clinical signs of insufficiency heart. The occurrence of symptoms should cause aortic valve replacement because at this stage the prognosis becomes unfavorable with a risk of death by cardiac decompensation or sudden death.
The two pillars of the diagnosis of severity are the evaluation of functional aortic valve area and the average transvalvular gradient. The tight aortic stenosis is defined for a functional aortic area <1cm² or 0.6cm² / m² and a mean tranvular gradient> 40 mmHg.
Patient survival data and / or a possible complication or indication for surgery will be evaluated periodically either during a standard follow-up consultation if patients are followed in the referral center or by telephone contact with the attending physician or cardiologist. . In case of death, the cause and date will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic valve stenosis | – | Other: Transthoracic ultrasoundThe participants will be identified from the Transthoracic ultrasound echocardiography reports of the echocardiography laboratory of the University Hospital of Amiens and CH Philibert for the retrospective part. They are analyzed during echocardiography at the echocardiography laboratory of two participating centers when a diagnosis of aortic stenosis is made. Patients are informed by newsletter. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be identified from the transthoracic echocardiography reports of the echocardiography laboratory of CHU Amiens and CH Saint Philibert for the retrospective part. They are prospectively identified during echocardiography performed in the echocardiography laboratory of the two participating centers when a diagnosis of aortic stenosis is made. Patients will be informed by newsletter.
Key inclusion criteria (2 listed)
- Retrospectively, all patients examined from January 1, 2000 to November 2014 will be included in the echocardiography laboratory whose objective examination is a narrowing of the aortic valve (maximum transaortic velocity ≥2.5 m / s).
- Aortic stenosis may be known in the past.
Key exclusion criteria (3 listed)
- Refusal of the patient to participate in the study.
- Patients who have previously had aortic valve surgery before being examined in the echocardiography laboratory.
- Patients who can not be contacted or who do not respond will not be included in the database.
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 |
|---|---|---|
| Transthoracic ultrasoundPatients are prospectively identified during echocardiography performed in the echocardiography laboratory of the two participating centers when a diagnosis of aortic stenosis is made. | Other | Aortic valve stenosis |
Primary outcome
Prognosis of asymptomatic and symptomatic aortic valve stenosis
Time frame: 6 years
Aortic valve stenosis (Rao) is the most common valvulopathy in Western countries. Cardiac EchoDoppler represents the reference method of evaluation of Rao and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low-gradient and low-gradient Rao is discussed.) The main objective of this work is to study the prognosis of asymptomatic and symptomatic aortic valve stenosis. To Look for predictors of prognosis and To Evaluate the impact of comorbidities on the prognosis of RAo Evaluate operative indications and specify the short and long term outcome after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Christophe TRIBOUILLOY, MD, PhD principal investigator
CHU AMIENS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morality, run by Centre Hospitalier Universitaire, Amiens 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe TRIBOUILLOY, MD, PhD (0322087251, Tribouilloy.Christophe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognosis of asymptomatic and symptomatic aortic valve stenosis (time frame: 6 years). 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 25 Jun 2026.