Clinical trial NCT03411317: Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling
Official title: Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling (AS-PROGRESSION)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Valve Stenosis
Keywords: Aortic stenosis
progression
Left ventricular remodeling
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 350
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 not 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 evaluate prospectively the progression and impact of AS in 500 patients using clinical, biological, echocardiographic and MRI parameters performed annually.


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

Primary outcomes:
measure: Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
timeFrame: Year 1
measure: Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
timeFrame: Year 2
measure: Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
timeFrame: Year 3
measure: Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
timeFrame: Year 4
Secondary outcomes:
measure: Determinants of left ventricular remodeling
timeFrame: Year 1
measure: Determinants of left ventricular remodeling
timeFrame: Year 2
measure: Determinants of left ventricular remodeling
timeFrame: Year 3
measure: Determinants of left ventricular remodeling
timeFrame: Year 4
measure: Progression of left ventricular remodeling
timeFrame: Year 1
measure: Progression of left ventricular remodeling
timeFrame: Year 2
measure: Progression of left ventricular remodeling
timeFrame: Year 3
measure: Progression of left ventricular remodeling
timeFrame: Year 4
measure: Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
timeFrame: Year 1
measure: Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
timeFrame: Year 2
measure: Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
timeFrame: Year 3
measure: Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
timeFrame: Year 4
Other outcomes:
Locations:
city: Rouen
country: France
facility: UH Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Helene Eltchaninoff, Pr
role: PRINCIPAL_INVESTIGATOR
References: