Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling (AS-PROGRESSION)

Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling (AS-PROGRESSION)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Helene Eltchaninoff, Pr; Phone Number: +33232888232; Email: helene.eltchaninoff@chu-rouen.fr
• Study Contact Backup: Name: Delphine Béziau-Gasnier, PhD; Phone Number: +33232886766; Email: delphine.beziau-gasnier@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • UH Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with at least moderate aortic stenosis and in whom an intervention is not programmed or indicated

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis	CT scan and MRI	Year 1
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis	CT scan and MRI	Year 2
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis	CT scan and MRI	Year 3
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis	CT scan and MRI	Year 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determinants of left ventricular remodeling	MRI and echocardiography	Year 1
Determinants of left ventricular remodeling	MRI and echocardiography	Year 2
Determinants of left ventricular remodeling	MRI and echocardiography	Year 3
Determinants of left ventricular remodeling	MRI and echocardiography	Year 4
Progression of left ventricular remodeling	MRI and echocardiography	Year 1
Progression of left ventricular remodeling	MRI and echocardiography	Year 2
Progression of left ventricular remodeling	MRI and echocardiography	Year 3
Progression of left ventricular remodeling	MRI and echocardiography	Year 4
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis	Occurrence of clinical events, MRI, CT scan and echocardiography	Year 1
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis	Occurrence of clinical events, MRI, CT scan and echocardiography	Year 2
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis	Occurrence of clinical events, MRI, CT scan and echocardiography	Year 3
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis	Occurrence of clinical events, MRI, CT scan and echocardiography	Year 4

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Helene Eltchaninoff, Pr, ROUEN university hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Aortic stenosis; progression; Left ventricular remodeling
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Disease Progression; Aortic Valve Stenosis; Constriction, Pathologic; Ventricular Remodeling
• Other Study ID Numbers: 2017/081/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No