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

Sponsor
University Hospital, Rouen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03411304
Collaborator
(none)
440
Enrollment
1
Location
89.9
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    440 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)
    Actual Study Start Date :
    Dec 5, 2017
    Anticipated Primary Completion Date :
    Jun 1, 2025
    Anticipated Study Completion Date :
    Jun 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of clinical events according to left ventricular remodeling [Year 1]

      Echocardiography and MRI

    2. Occurrence of clinical events according to left ventricular remodeling [Year 2]

      Echocardiography and MRI

    3. Occurrence of clinical events according to left ventricular remodeling [Year 3]

      Echocardiography and MRI

    4. Occurrence of clinical events according to left ventricular remodeling [Year 4]

      Echocardiography and MRI

    Secondary Outcome Measures

    1. Evolution of left ventricular remodeling after aortic valvular replacement [Year 1]

      Echocardiography and MRI

    2. Prognostic value of persistence and type of left ventricular remodeling [Year 1]

      Echocardiography and MRI Occurence of clinical events

    3. Prognostic value of fibrosis [Year 1]

      Echocardiography and MRI Occurence of clinical events

    4. Prognostic value of biomarkers [Year 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UH Rouen Rouen France

    Sponsors and Collaborators

    • University Hospital, Rouen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Rouen
    ClinicalTrials.gov Identifier:
    NCT03411304
    Other Study ID Numbers:
    • 2017/080/HP
    First Posted:
    Jan 26, 2018
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Rouen
    Aortic valvular replacement
    Aortic stenosis
    Left ventricular remodeling
    biomarkers
    Additional relevant MeSH terms:
    Aortic Valve Stenosis
    Constriction, Pathologic
    Ventricular Remodeling

    Study Results

    No Results Posted as of Sep 29, 2021