Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling (AS-PROGRESSION)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- University Hospital, Rouen
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
- Status
- Active, Not Recruiting
- Last Updated
- last year
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 evaluate prospectively the progression and impact of AS in 500 patients using clinical, biological, echocardiographic and MRI parameters performed annually.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
Time Frame: Year 4
CT scan and MRI
Secondary Outcomes
- Determinants of left ventricular remodeling(Year 4)
- Progression of left ventricular remodeling(Year 4)
- Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis(Year 4)