Ireland
--:--IST
Active, not recruiting Observational

Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling

NCT03411317 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2017-12-11
Last updated
2024-12-09

Condition(s) studied

Aortic Valve Stenosis

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 evaluate prospectively the progression and impact of AS in 500 patients using clinical, biological, echocardiographic and MRI parameters performed annually.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Aortic stenosis (peak aortic valve velocity (Vmax) ≥2.5m/s ) Exclusion Criteria: * rheumatismal or congenital aortic stenosis * aortic insufficiency (grade \>= 2/4) * Associated valvulopathy (grade \>= 2/4) * Angina, syncope, dyspnea NYHA 3-4 * Heart failure antecedent * Myocardial infarction antecedent * Severe renal failure * indication of Aortic Valve Replacement (Surgery or TAVI) * Cardiac surgery (Aorta abdominal) antecedent * Complex congenital cardiopathy

Primary outcome measure(s)

  • Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis — Year 1
    CT scan and MRI
  • Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis — Year 2
    CT scan and MRI
  • Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis — Year 3
    CT scan and MRI
  • Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis — Year 4
    CT scan and MRI

Trial sites (1)

FacilityCityRegionStatus
UH Rouen Rouen France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03411317 on ClinicalTrials.gov ↗ ← All trials in France