Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement

Study Overview
=================
Brief Summary
-----------------
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI). AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified. The aim of the study is to characterize prospectively the left ventricular remodeling and assess its changes after AVR and within 1 year in 500 patients using clinical, biological, echocardiographic and MRI parameters.

Official Title
-----------------
Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)

Conditions
-----------------
Aortic Valve Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aortic stenosis Indication of Aortic Valve Replacement (Surgery or TAVI) Exclusion Criteria: Rheumatismal or congenital aortic stenosis Aortic insufficiency (grade >= 2/4) Associated valvulopathy (grade >= 2/4) Myocardial infarction antecedent Severe renal failure Cardiac surgery (Aorta abdominal) antecedent Complex congenital cardiopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of clinical events according to left ventricular remodeling | Echocardiography and MRI | Year 1 | 
| Occurrence of clinical events according to left ventricular remodeling | Echocardiography and MRI | Year 2 | 
| Occurrence of clinical events according to left ventricular remodeling | Echocardiography and MRI | Year 3 | 
| Occurrence of clinical events according to left ventricular remodeling | Echocardiography and MRI | Year 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of left ventricular remodeling after aortic valvular replacement | Echocardiography and MRI | Year 1 | 
| Prognostic value of persistence and type of left ventricular remodeling | Echocardiography and MRI Occurence of clinical events | Year 1 | 
| Prognostic value of fibrosis | Echocardiography and MRI Occurence of clinical events | Year 1 | 
| Prognostic value of biomarkers |  | Year 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic valvular replacement, Aortic stenosis, Left ventricular remodeling, biomarkers