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NCT Number: NCT03411304

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UH Rouen

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Primary outcomes

  1. Occurrence of clinical events according to left ventricular remodeling

    Time frame: Year 1

    Echocardiography and MRI

  2. Occurrence of clinical events according to left ventricular remodeling

    Time frame: Year 2

    Echocardiography and MRI

  3. Occurrence of clinical events according to left ventricular remodeling

    Time frame: Year 3

    Echocardiography and MRI

  4. Occurrence of clinical events according to left ventricular remodeling

    Time frame: Year 4

    Echocardiography and MRI

Secondary outcomes

  1. Evolution of left ventricular remodeling after aortic valvular replacement

    Time frame: Year 1

    Echocardiography and MRI

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

    Time frame: Year 1

    Echocardiography and MRI Occurence of clinical events

  3. Prognostic value of fibrosis

    Time frame: Year 1

    Echocardiography and MRI Occurence of clinical events

  4. Prognostic value of biomarkers

    Time frame: Year 1

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2018
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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