Valvular Aortic Stenosis Prognosis Study

Morality Clinical Trial

— EPRAoV  

Official title:

Valvular Aortic Stenosis Prognosis Study: Prospective and Retrospective Follow-up of a Cohort of Patients With Aortic Valve Narrowing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03628313
• Other study ID #: RNI2014-16
• Status: Recruiting
• Start date: September 1, 2015
• Est. completion date: July 2025

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Christophe TRIBOUILLOY, MD, PhD
• Phone: 0322087251
• Email: Tribouilloy.Christophe[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Morality

Intervention

Other:
• Transthoracic ultrasound
Patients are prospectively identified during echocardiography performed in the echocardiography laboratory of the two participating centers when a diagnosis of aortic stenosis is made.

Locations

Country	Name	City	State
France	Chu Amiens-Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 years