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

Active, not recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT03411317
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-21
• Study Start: 2017-12-11
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis	Year 4	CT scan and MRI

Secondary Outcome Measures

Name	Time	Method
Determinants of left ventricular remodeling	Year 4	MRI and echocardiography
Progression of left ventricular remodeling	Year 4	MRI and echocardiography
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis	Year 4	Occurrence of clinical events, MRI, CT scan and echocardiography

Trial Locations

Locations (1)

UH Rouen; 🇫🇷 Rouen, France