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

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ClinicalTrials.gov Identifier: NCT03411317
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.


Condition or disease
Aortic Valve Stenosis

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling (AS-PROGRESSION)
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411317


Contacts
Contact: Helene Eltchaninoff, Pr +33232888232 helene.eltchaninoff@chu-rouen.fr
Contact: Delphine Béziau-Gasnier, PhD +33232886766 delphine.beziau-gasnier@chu-rouen.fr

Locations
France
UH Rouen Recruiting
Rouen, France
Contact: Hélène Eltchaninoff, MD    +33232888232    helene.eltchaninoff@chu-rouen.fr   
Contact: Delphine Beziau-Gasnier, PhD    +33232886766    delphine.beziau-gasnier@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Helene Eltchaninoff, Pr Rouen University Hospital

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT03411317     History of Changes
Other Study ID Numbers: 2017/081/HP
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Rouen:
Aortic stenosis
progression
Left ventricular remodeling

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Disease Progression
Ventricular Remodeling
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction