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NCT03411304 Clinical Trial

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

Aortic Valve Stenosis Clinical Trial

Official title:
Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03411304
Other study ID # 2017/080/HP
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 5, 2017
Est. completion date June 2025

Study information
Verified date May 2023
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority
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 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 440
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

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 Occurrence of clinical events according to left ventricular remodeling Echocardiography and MRI Year 1
Primary Occurrence of clinical events according to left ventricular remodeling Echocardiography and MRI Year 2
Primary Occurrence of clinical events according to left ventricular remodeling Echocardiography and MRI Year 3
Primary Occurrence of clinical events according to left ventricular remodeling Echocardiography and MRI Year 4
Secondary Evolution of left ventricular remodeling after aortic valvular replacement Echocardiography and MRI Year 1
Secondary Prognostic value of persistence and type of left ventricular remodeling Echocardiography and MRI Occurence of clinical events Year 1
Secondary Prognostic value of fibrosis Echocardiography and MRI Occurence of clinical events Year 1
Secondary Prognostic value of biomarkers Year 1
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