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Active, not recruitingNCT03411317AS-PROGRESSIONUpdated Dec 9, 2024

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

An observational study in Aortic Valve Stenosis, sponsored by University Hospital, Rouen. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by University Hospital, Rouen · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
350
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aortic Valve Stenosis

Keywords

  • Aortic stenosis
  • progression
  • Left ventricular remodeling
03

In context

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's planned enrollment of 350 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.

Browse University Hospital, Rouen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • rheumatismal or congenital aortic stenosis
  • aortic insufficiency (grade >= 2/4)
  • Associated valvulopathy (grade >= 2/4)
  • Angina, syncope, dyspnea 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
350 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    CT scan and MRI

    Time frame: Year 1

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

    CT scan and MRI

    Time frame: Year 2

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

    CT scan and MRI

    Time frame: Year 3

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

    CT scan and MRI

    Time frame: Year 4

Secondary outcomes

  1. Determinants of left ventricular remodeling

    MRI and echocardiography

    Time frame: Year 1

  2. Determinants of left ventricular remodeling

    MRI and echocardiography

    Time frame: Year 2

  3. Determinants of left ventricular remodeling

    MRI and echocardiography

    Time frame: Year 3

  4. Determinants of left ventricular remodeling

    MRI and echocardiography

    Time frame: Year 4

  5. Progression of left ventricular remodeling

    MRI and echocardiography

    Time frame: Year 1

  6. Progression of left ventricular remodeling

    MRI and echocardiography

    Time frame: Year 2

  7. Progression of left ventricular remodeling

    MRI and echocardiography

    Time frame: Year 3

  8. Progression of left ventricular remodeling

    MRI and echocardiography

    Time frame: Year 4

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

    Occurrence of clinical events, MRI, CT scan and echocardiography

    Time frame: Year 1

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

    Occurrence of clinical events, MRI, CT scan and echocardiography

    Time frame: Year 2

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

    Occurrence of clinical events, MRI, CT scan and echocardiography

    Time frame: Year 3

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

    Occurrence of clinical events, MRI, CT scan and echocardiography

    Time frame: Year 4

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for Dec 2025, 96 months after the start.

Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's planned 96 months is above that.

Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2017
First posted
Jan 26, 2018
StartActual
Dec 11, 2017
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Dec 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03411317
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Jan 26, 2018
Start date
Dec 11, 2017
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Dec 9, 2024

Study contacts

Helene Eltchaninoff, Pr
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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