Clinical trial NCT03628313: Valvular Aortic Stenosis Prognosis Study
Official title: Valvular Aortic Stenosis Prognosis Study: Prospective and Retrospective Follow-up of a Cohort of Patients With Aortic Valve Narrowing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Morality
Keywords: Echoacrdiography
EchoDoppler
Aortic valve stenosis
Prognosis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Prognosis of asymptomatic and symptomatic aortic valve stenosis
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens-Picardie
Study officials:
affiliation: CHU AMIENS
name: Christophe TRIBOUILLOY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: