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NCT Number: NCT03411317

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Disease Attributes Disease Progression Heart Diseases Heart Valve Diseases Pathologic Processes 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 (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

Treatment and study plan

Primary outcomes

  1. Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis

    Time frame: Year 1

    CT scan and MRI

  2. Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis

    Time frame: Year 2

    CT scan and MRI

  3. Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis

    Time frame: Year 3

    CT scan and MRI

  4. Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis

    Time frame: Year 4

    CT scan and MRI

Secondary outcomes

  1. Determinants of left ventricular remodeling

    Time frame: Year 1

    MRI and echocardiography

  2. Determinants of left ventricular remodeling

    Time frame: Year 2

    MRI and echocardiography

  3. Determinants of left ventricular remodeling

    Time frame: Year 3

    MRI and echocardiography

  4. Determinants of left ventricular remodeling

    Time frame: Year 4

    MRI and echocardiography

  5. Progression of left ventricular remodeling

    Time frame: Year 1

    MRI and echocardiography

  6. Progression of left ventricular remodeling

    Time frame: Year 2

    MRI and echocardiography

  7. Progression of left ventricular remodeling

    Time frame: Year 3

    MRI and echocardiography

  8. Progression of left ventricular remodeling

    Time frame: Year 4

    MRI and echocardiography

  9. Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis

    Time frame: Year 1

    Occurrence of clinical events, MRI, CT scan and echocardiography

  10. Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis

    Time frame: Year 2

    Occurrence of clinical events, MRI, CT scan and echocardiography

  11. Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis

    Time frame: Year 3

    Occurrence of clinical events, MRI, CT scan and echocardiography

  12. Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis

    Time frame: Year 4

    Occurrence of clinical events, MRI, CT scan and echocardiography

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: AS-PROGRESSION

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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