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Active, not recruitingNCT03411304Updated Dec 9, 2024

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

An observational study in Aortic Valve Stenosis, sponsored by University Hospital, Rouen. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by University Hospital, Rouen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
440
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aortic Valve Stenosis

Keywords

  • Aortic valvular replacement
  • Aortic stenosis
  • Left ventricular remodeling
  • biomarkers
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

  • Aortic stenosis
  • Indication of Aortic Valve Replacement (Surgery or TAVI)

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
440 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Occurrence of clinical events according to left ventricular remodeling

    Echocardiography and MRI

    Time frame: Year 1

  2. Occurrence of clinical events according to left ventricular remodeling

    Echocardiography and MRI

    Time frame: Year 2

  3. Occurrence of clinical events according to left ventricular remodeling

    Echocardiography and MRI

    Time frame: Year 3

  4. Occurrence of clinical events according to left ventricular remodeling

    Echocardiography and MRI

    Time frame: Year 4

Secondary outcomes

  1. Evolution of left ventricular remodeling after aortic valvular replacement

    Echocardiography and MRI

    Time frame: Year 1

  2. Prognostic value of persistence and type of left ventricular remodeling

    Echocardiography and MRI Occurence of clinical events

    Time frame: Year 1

  3. Prognostic value of fibrosis

    Echocardiography and MRI Occurence of clinical events

    Time frame: Year 1

  4. Prognostic value of biomarkers

    Time frame: Year 1

06

Study locations

1 site
  • UH Rouen
    Rouen, France
07

Registry details

Key details

Study ID
NCT03411304
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Jan 26, 2018
Start date
Dec 5, 2017
Primary completion
Jun 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Dec 9, 2024

Study contacts

Helene Eltchaninoff, Pr
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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