Valvular Aortic Stenosis Prognosis Study (EPRAoV)

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.

Study Overview

• Status: Recruiting
• Conditions: Morality
• Intervention / Treatment: Other: Transthoracic ultrasound

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Christophe TRIBOUILLOY, MD, PhD; Phone Number: 0322087251; Email: Tribouilloy.Christophe@chu-amiens.fr
• Study Contact Backup: Name: Sylvestre MARECHAUX, MD, PhD; Phone Number: 0320225050; Email: sylvestre.marechaux@yahoo.fr

Study Locations

• France
  • Amiens, France, 80000
    • Recruiting
    • CHU Amiens-Picardie
    • Contact: TRIBOUILLOY CHRISTOPHE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ANTICIPATED): July 1, 2025
• Study Completion (ANTICIPATED): July 1, 2025

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (ACTUAL): August 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Prognosis; Aortic valve stenosis; Echoacrdiography; EchoDoppler
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: RNI2014-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No