Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 440
- Locations
- 1
- Primary Endpoint
- Occurrence of clinical events according to left ventricular remodeling
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Occurrence of clinical events according to left ventricular remodeling
Time Frame: Year 4
Echocardiography and MRI
Secondary Outcomes
- Evolution of left ventricular remodeling after aortic valvular replacement(Year 1)
- Prognostic value of fibrosis(Year 1)
- Prognostic value of biomarkers(Year 1)
- Prognostic value of persistence and type of left ventricular remodeling(Year 1)