Aortic Valve StenosisAS-PROGRESSIONNCT03411317
Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling
An observational study of Aortic Valve Stenosis, run by University Hospital, Rouen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2017to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with at least moderate aortic stenosis and in whom an intervention is not programmed or indicated
Who may be able to join
- Aortic stenosis (peak aortic valve velocity (Vmax) ≥2.5m/s )
Who cannot join
- 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
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- Severe renal failure
- indication of Aortic Valve Replacement (Surgery or TAVI)
- Cardiac surgery (Aorta abdominal) antecedent
- Complex congenital cardiopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling (AS-PROGRESSION)
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.
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic stenosis, progression, Left ventricular remodeling
- Medical subject headings
- Aortic Valve Stenosis, Disease Progression, Ventricular Remodeling
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
CT scan and MRI
Measured: Year 1
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
CT scan and MRI
Measured: Year 2
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
CT scan and MRI
Measured: Year 3
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
CT scan and MRI
Measured: Year 4
Secondary outcomes (12)
Determinants of left ventricular remodeling
MRI and echocardiography
Measured: Year 1
Determinants of left ventricular remodeling
MRI and echocardiography
Measured: Year 2
Determinants of left ventricular remodeling
MRI and echocardiography
Measured: Year 3
Determinants of left ventricular remodeling
MRI and echocardiography
Measured: Year 4
Progression of left ventricular remodeling
MRI and echocardiography
Measured: Year 1
Progression of left ventricular remodeling
MRI and echocardiography
Measured: Year 2
Progression of left ventricular remodeling
MRI and echocardiography
Measured: Year 3
Progression of left ventricular remodeling
MRI and echocardiography
Measured: Year 4
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
Occurrence of clinical events, MRI, CT scan and echocardiography
Measured: Year 1
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
Occurrence of clinical events, MRI, CT scan and echocardiography
Measured: Year 2
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
Occurrence of clinical events, MRI, CT scan and echocardiography
Measured: Year 3
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
Occurrence of clinical events, MRI, CT scan and echocardiography
Measured: Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start11 Dec 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Eltchaninoff, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411317
- Sponsor's protocol ID
- 2017/081/HP
- Acronym
- AS-PROGRESSION
- Status last verified
- Dec 2024
- First submitted
- 21 Aug 2017
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling (AS-PROGRESSION)
- ClinicalTrials.gov ID
- NCT03411317
- Acronym / sponsor ID
- AS-PROGRESSION / 2017/081/HP
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic stenosis, progression, Left ventricular remodeling
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with at least moderate aortic stenosis and in whom an intervention is not programmed or indicated
Key inclusion criteria (1 listed)
- Aortic stenosis (peak aortic valve velocity (Vmax) ≥2.5m/s )
Key exclusion criteria (10 listed)
- rheumatismal or congenital aortic stenosis
- aortic insufficiency (grade >= 2/4)
- Associated valvulopathy (grade >= 2/4)
- Angina, syncope, dyspnea NYHA 3-4
- Heart failure antecedent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
Time frame: Year 1
CT scan and MRI
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
Time frame: Year 2
CT scan and MRI
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
Time frame: Year 3
CT scan and MRI
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis
Time frame: Year 4
CT scan and MRI
12 secondary outcomes
Determinants of left ventricular remodeling
Time frame: Year 1
Determinants of left ventricular remodeling
Time frame: Year 2
Determinants of left ventricular remodeling
Time frame: Year 3
Determinants of left ventricular remodeling
Time frame: Year 4
Progression of left ventricular remodeling
Time frame: Year 1
Progression of left ventricular remodeling
Time frame: Year 2
Progression of left ventricular remodeling
Time frame: Year 3
Progression of left ventricular remodeling
Time frame: Year 4
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
Time frame: Year 1
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
Time frame: Year 2
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
Time frame: Year 3
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis
Time frame: Year 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene Eltchaninoff, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis (time frame: Year 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.