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

NCT03411317 | Active Not Recruiting

• 1 other identifier: 2017/081/HP
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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

Conditions

Aortic Valve Stenosis

Keywords

Aortic stenosis; progression; Left ventricular remodeling

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Determinants of left ventricular remodeling

  Year 1

• Determinants of left ventricular remodeling

  Year 2

• Determinants of left ventricular remodeling

  Year 3

• Determinants of left ventricular remodeling

  Year 4

• Progression of left ventricular remodeling

  Year 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Aortic stenosis (peak aortic valve velocity (Vmax) ≥2.5m/s )

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

UH Rouen

Rouen, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Disease Progression; Ventricular Remodeling

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• Helene Eltchaninoff, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: January 26, 2018
• Study Start: December 11, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

FR (1)