Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement

Active, not recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT03411304
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-21
• Study Start: 2017-12-05
• 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: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of clinical events according to left ventricular remodeling	Year 4	Echocardiography and MRI

Secondary Outcome Measures

Name	Time	Method
Evolution of left ventricular remodeling after aortic valvular replacement	Year 1	Echocardiography and MRI
Prognostic value of fibrosis	Year 1	Echocardiography and MRI Occurence of clinical events
Prognostic value of biomarkers	Year 1
Prognostic value of persistence and type of left ventricular remodeling	Year 1	Echocardiography and MRI Occurence of clinical events

Trial Locations

Locations (1)

UH Rouen; 🇫🇷 Rouen, France