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

N/AActive Not RecruitingNCT03411317

University Hospital, Rouen350 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Aortic Valve Stenosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis

CT scan and MRI

Time frame: Year 1

Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis

CT scan and MRI

Time frame: Year 2

Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis

CT scan and MRI

Time frame: Year 3

Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis

CT scan and MRI

Time frame: Year 4

Secondary Outcomes

Determinants of left ventricular remodeling

MRI and echocardiography

Time frame: Year 1

Determinants of left ventricular remodeling

MRI and echocardiography

Time frame: Year 2

Determinants of left ventricular remodeling

MRI and echocardiography

Time frame: Year 3

Determinants of left ventricular remodeling

MRI and echocardiography

Time frame: Year 4

Progression of left ventricular remodeling

MRI and echocardiography

Time frame: Year 1

Progression of left ventricular remodeling

MRI and echocardiography

Time frame: Year 2

Progression of left ventricular remodeling

MRI and echocardiography

Time frame: Year 3

Progression of left ventricular remodeling

MRI and echocardiography

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Year 4