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

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ClinicalTrials.gov Identifier: NCT03411304
Recruitment Status : Active, not recruiting
First Posted : January 26, 2018
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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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
Aortic Valve Stenosis

Study Design
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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 : December 5, 2017
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of clinical events according to left ventricular remodeling [ Time Frame: Year 1 ]
    Echocardiography and MRI

  2. Occurrence of clinical events according to left ventricular remodeling [ Time Frame: Year 2 ]
    Echocardiography and MRI

  3. Occurrence of clinical events according to left ventricular remodeling [ Time Frame: Year 3 ]
    Echocardiography and MRI

  4. Occurrence of clinical events according to left ventricular remodeling [ Time Frame: Year 4 ]
    Echocardiography and MRI


Secondary Outcome Measures :
  1. Evolution of left ventricular remodeling after aortic valvular replacement [ Time Frame: Year 1 ]
    Echocardiography and MRI

  2. Prognostic value of persistence and type of left ventricular remodeling [ Time Frame: Year 1 ]
    Echocardiography and MRI Occurence of clinical events

  3. Prognostic value of fibrosis [ Time Frame: Year 1 ]
    Echocardiography and MRI Occurence of clinical events

  4. Prognostic value of biomarkers [ Time Frame: Year 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411304


Locations
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France
UH Rouen
Rouen, France
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Helene Eltchaninoff, Pr Rouen University Hospital
More Information
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT03411304    
Other Study ID Numbers: 2017/080/HP
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021

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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:
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Aortic Valve Stenosis
Constriction, Pathologic
Ventricular Remodeling
Pathological Conditions, Anatomical
Aortic Valve Disease
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction