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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-05

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Aortic Valve Stenosis

Keywords

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Aortic valvular replacement Aortic stenosis Left ventricular remodeling biomarkers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helene Eltchaninoff, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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UH Rouen

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2017/080/HP

Identifier Type: -

Identifier Source: org_study_id