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)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03411304

Enrollment

440

Registered

2018-01-26

Start date

2017-12-05

Completion date

2025-06-30

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

Aortic valvular replacement, Aortic stenosis, Left ventricular remodeling, biomarkers

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of clinical events according to left ventricular remodeling	Year 1	Echocardiography and MRI

Secondary

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

Countries

France

Outcome results