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

NCT03411304 | Active Not Recruiting

• 1 other identifier: 2017/080/HP
• Study Type: observational
• Target: 440
• 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 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.

Conditions

Aortic Valve Stenosis

Keywords

Aortic valvular replacement; Aortic stenosis; Left ventricular remodeling; biomarkers

Outcome Measures

Primary Outcomes (4)

• Occurrence of clinical events according to left ventricular remodeling

  Echocardiography and MRI

  Year 1

• Occurrence of clinical events according to left ventricular remodeling

  Echocardiography and MRI

  Year 2

• Occurrence of clinical events according to left ventricular remodeling

  Echocardiography and MRI

  Year 3

• Occurrence of clinical events according to left ventricular remodeling

  Echocardiography and MRI

  Year 4

Secondary Outcomes (4)

• Evolution of left ventricular remodeling after aortic valvular replacement

  Year 1

• Prognostic value of persistence and type of left ventricular remodeling

  Year 1

• Prognostic value of fibrosis

  Year 1

• Prognostic value of biomarkers

  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 programmed or indicated

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

UH Rouen

Rouen, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Ventricular Remodeling

Condition Hierarchy (Ancestors)

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

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 5, 2017
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

FR (1)