Clinical trial NCT03411304: Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement
Official title: Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Valve Stenosis
Keywords: Aortic valvular replacement
Aortic stenosis
Left ventricular remodeling
biomarkers
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with at least moderate aortic stenosis and in whom an intervention is programmed or indicated

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.


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

Primary outcomes:
measure: Occurrence of clinical events according to left ventricular remodeling
timeFrame: Year 1
measure: Occurrence of clinical events according to left ventricular remodeling
timeFrame: Year 2
measure: Occurrence of clinical events according to left ventricular remodeling
timeFrame: Year 3
measure: Occurrence of clinical events according to left ventricular remodeling
timeFrame: Year 4
Secondary outcomes:
measure: Evolution of left ventricular remodeling after aortic valvular replacement
timeFrame: Year 1
measure: Prognostic value of persistence and type of left ventricular remodeling
timeFrame: Year 1
measure: Prognostic value of fibrosis
timeFrame: Year 1
measure: Prognostic value of biomarkers
timeFrame: Year 1
Other outcomes:
Locations:
city: Rouen
country: France
facility: UH Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Helene Eltchaninoff, Pr
role: PRINCIPAL_INVESTIGATOR
References: