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

Aortic Valve Stenosis Clinical Trial

— AS-PROGRESSION  

Official title:

Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling (AS-PROGRESSION)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03411317
• Other study ID #: 2017/081/HP
• Status: Active, not recruiting
• Start date: December 11, 2017
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Disease Progression
• Ventricular Remodeling

Locations

Country	Name	City	State
France	UH Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis	CT scan and MRI	Year 1
Primary	Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis	CT scan and MRI	Year 2
Primary	Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis	CT scan and MRI	Year 3
Primary	Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis	CT scan and MRI	Year 4
Secondary	Determinants of left ventricular remodeling	MRI and echocardiography	Year 1
Secondary	Determinants of left ventricular remodeling	MRI and echocardiography	Year 2
Secondary	Determinants of left ventricular remodeling	MRI and echocardiography	Year 3
Secondary	Determinants of left ventricular remodeling	MRI and echocardiography	Year 4
Secondary	Progression of left ventricular remodeling	MRI and echocardiography	Year 1
Secondary	Progression of left ventricular remodeling	MRI and echocardiography	Year 2
Secondary	Progression of left ventricular remodeling	MRI and echocardiography	Year 3
Secondary	Progression of left ventricular remodeling	MRI and echocardiography	Year 4
Secondary	Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis	Occurrence of clinical events, MRI, CT scan and echocardiography	Year 1
Secondary	Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis	Occurrence of clinical events, MRI, CT scan and echocardiography	Year 2
Secondary	Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis	Occurrence of clinical events, MRI, CT scan and echocardiography	Year 3
Secondary	Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis	Occurrence of clinical events, MRI, CT scan and echocardiography	Year 4