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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis

• Study Type: Observational
• Enrollment (Actual): 440

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • UH Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with at least moderate aortic stenosis and in whom an intervention is programmed or indicated

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of clinical events according to left ventricular remodeling	Echocardiography and MRI	Year 1
Occurrence of clinical events according to left ventricular remodeling	Echocardiography and MRI	Year 2
Occurrence of clinical events according to left ventricular remodeling	Echocardiography and MRI	Year 3
Occurrence of clinical events according to left ventricular remodeling	Echocardiography and MRI	Year 4

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Helene Eltchaninoff, Pr, Rouen University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2017
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: biomarkers; Aortic stenosis; Aortic valvular replacement; Left ventricular remodeling
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic; Ventricular Remodeling
• Other Study ID Numbers: 2017/080/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No