Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling

Study Overview
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Brief Summary
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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 evaluate prospectively the progression and impact of AS in 500 patients using clinical, biological, echocardiographic and MRI parameters performed annually.

Official Title
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Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling (AS-PROGRESSION)

Conditions
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Aortic Valve Stenosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aortic stenosis (peak aortic valve velocity (Vmax) ≥2.5m/s ) Exclusion Criteria: rheumatismal or congenital aortic stenosis aortic insufficiency (grade >= 2/4) Associated valvulopathy (grade >= 2/4) Angina, syncope, dyspnea NYHA 3-4 Heart failure antecedent Myocardial infarction antecedent Severe renal failure indication of Aortic Valve Replacement (Surgery or TAVI) Cardiac surgery (Aorta abdominal) antecedent Complex congenital cardiopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis | CT scan and MRI | Year 1 | 
| Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis | CT scan and MRI | Year 2 | 
| Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis | CT scan and MRI | Year 3 | 
| Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis | CT scan and MRI | Year 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determinants of left ventricular remodeling | MRI and echocardiography | Year 1 | 
| Determinants of left ventricular remodeling | MRI and echocardiography | Year 2 | 
| Determinants of left ventricular remodeling | MRI and echocardiography | Year 3 | 
| Determinants of left ventricular remodeling | MRI and echocardiography | Year 4 | 
| Progression of left ventricular remodeling | MRI and echocardiography | Year 1 | 
| Progression of left ventricular remodeling | MRI and echocardiography | Year 2 | 
| Progression of left ventricular remodeling | MRI and echocardiography | Year 3 | 
| Progression of left ventricular remodeling | MRI and echocardiography | Year 4 | 
| Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis | Occurrence of clinical events, MRI, CT scan and echocardiography | Year 1 | 
| Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis | Occurrence of clinical events, MRI, CT scan and echocardiography | Year 2 | 
| Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis | Occurrence of clinical events, MRI, CT scan and echocardiography | Year 3 | 
| Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis | Occurrence of clinical events, MRI, CT scan and echocardiography | Year 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic stenosis, progression, Left ventricular remodeling