Severe Aortic StenosisALPINISTNCT06477042
Act on Quality of Life in Patients With aortIc Stenosis
An observational study of Severe Aortic Stenosis, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
Aortic stenosis (AS) is a degenerative process affecting the aortic valve that leads to sclerosis of the valve and limits its opening during cardiac contractions. The prognosis is poorly, with survival rates of only 15-50% at 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Stenosis
- What is being tested?
- Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score
- How many people
- 240 participants
- Where
- 4 sitesFrance
- Study dates
- 19 Dec 2024to 19 Dec 2027
- 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: Patient with indication of TAVI followed in four french cardiology department.
Who may be able to join
- Patients with symptomatic aortic stenosis (exertional dyspnea, angina, malaise/syncope)
- Indication for TAVI (valve area 1 cm² or 1 cm²/m² body surface area or mean transvalvular aortic gradient > 40 mmHg on ultrasound) validated in Heart Team
- Charlson score ≥ 5
- Social health care insurance affiliation
Who cannot join
- Patient refusing TAVI procedure
- CT scan not performed during the pre-TAVI assessment
- Patient unable to understand or answer quality-of-life questionnaires
- Pregnant or breast-feeding women
- Patients participating in other interventional research that may interfere with the present study with an exclusion period still in progress
- Persons under judicial protection
- Patients under guardianship, curators or safeguard of justice
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Service de Cardiologie - CHU Clermont Ferrand
Clermont-Ferrand, 63000
Géraud Souteyrand, MD, 04737513 ext. +33, gsouteyrand@chu-clermontferrand.fr
Géraud Souteyrand, MD
- Not yet recruiting
Service de Cardiologie
Lille, 59000
Eric VAN BELLE, MD, 032045962 ext. +33, ericvanbelle@aol.com
Eric Van Belle, MD
- Recruiting
Service de Cardiologie
Lyon, 69004
Pierre Lantelme, MD, 0472072536 ext. +33, pierre.lantelme@chu-lyon.fr
Julia Canterini, 04 27 85 66 28 ext. +33, julia.canterini@chu-lyon.fr
- Not yet recruiting
Service de Cardiologie - Institut Thorax Nantes
Nantes, 44000
Thibaut Manigold, MD, 0253482772 ext. +33, thibaut.manigold@chu-nantes.fr
Thibaut Manigold, MD
About this study
Official title: Act on Quality of Life in Poor Prognosis Aortic Stenosis Patients
Aortic stenosis (AS) is a degenerative process affecting the aortic valve that leads to sclerosis of the valve and limits its opening during cardiac contractions. The prognosis is poorly, with survival rates of only 15-50% at 5 years. AS has a major impact on quality of life, with severely limiting symptoms (dyspnea, chest pain,…) often leading to repeated hospitalizations. It is the most common valvular disease in Europe and North America, and its prevalence is increasing as the population ages. In Europe, 17% of the population is aged 65 or over; in France, this proportion will reach 30% by 2030, corresponding to 16 million people. The incidence of aortic valve sclerosis (early stage AS) is around 25% at age 65, rising to 48% after age 75. The prevalence of aortic valve disease is likely to continue to rise, given the expected evolution of the age pyramid.
There is no medical treatment able to slow down the degenerative process of the valve, and the only treatment is aortic valve replacement when the AS becomes constricted and the patient is eligible for an intervention. Aortic valve replacement has historically been performed surgically, with open-chest surgery to remove the damaged valve and replace it with a mechanical or biological valve prosthesis. Now Transcatheter Aortic Valve Implantation (TAVI) has replaced this procedure. This involves inserting a bioprosthesis crimped into a stent via an endovascular route, i.e. without opening the thorax. Deployment of the stent crushes the native valve, leaving the functional bioprosthesis in place.
Read more
Initially developed for patients contraindicated to surgery, TAVI is now offered as a first-line treatment for patients aged 75 and over.
Inexistent before 2010, the number of TAVIs equalled the number of surgeries by 2015, and TAVIs currently account for ¾ of aortic valve procedures (unpublished data).
- Conditions
- Severe Aortic Stenosis
- Being tested
- Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score
- Keywords
- TAVI, quality of life, Aortic Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scoreOther
Change in quality-of-life score assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) between the 2-month early visit and inclusion in the poor-prognosis group.
| Study group | Role | What they receive |
|---|---|---|
| Poor prognosis patients | Patients will performed the Quality Of Life Questionnaire (EQ-5D-5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) at baseline (day of the TAVI procedure) and 2 months post-TAVI. The CAPRI score will be calculated from the data of the pre TAVI assessment at the end of study participation (12 months) and will determine the group of the patient. The higher the score, the worse the prognosis. Receives: Other: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score | |
| Intermediate prognosis patients | Patients will performed the Quality Of Life Questionnaire (EQ-5D-5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) at baseline (day of the TAVI procedure) and 2 months post-TAVI. The CAPRI score will be calculated from the data of the pre TAVI assessment at the end of study participation (12 months) and will determine the group of the patient. The higher the score, the worse the prognosis Receives: Other: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score variation between the 2-months visit and inclusion.
Change in quality-of-life score assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) between the 2-month early visit and inclusion in the poor-prognosis group. The KCCQ-12 contains four subdomains: Physical Limitation, Symptom Frequency, Quality of Life, and Social Limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 the best possible health status
Measured: Day 0 and Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start19 Dec 2024
- Primary completion19 Dec 2027 (estimated)
- Study completion19 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477042
- Sponsor's protocol ID
- 69HCL22_0930
- Acronym
- ALPINIST
- Status last verified
- Jan 2025
- First submitted
- 18 Jun 2024
- Last updated
- 17 Jan 2025
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Act on Quality of Life in Poor Prognosis Aortic Stenosis Patients
- ClinicalTrials.gov ID
- NCT06477042
- Acronym / sponsor ID
- ALPINIST / 69HCL22_0930
- Conditions
- Severe Aortic Stenosis
- Keywords
- TAVI, quality of life, Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 19 Dec 2027 (estimated)
- Study completion
- 19 Dec 2027 (estimated)
- First posted
- 27 Jun 2024 (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 a degenerative process affecting the aortic valve that leads to sclerosis of the valve and limits its opening during cardiac contractions. The prognosis is poorly, with survival rates of only 15-50% at 5 years. AS has a major impact on quality of life, with severely limiting symptoms (dyspnea, chest pain,…) often leading to repeated hospitalizations. It is the most common valvular disease in Europe and North America, and its prevalence is increasing as the population ages. In Europe, 17% of the population is aged 65 or over; in France, this proportion will reach 30% by 2030, corresponding to 16 million people. The incidence of aortic valve sclerosis (early stage AS) is around 25% at age 65, rising to 48% after age 75. The prevalence of aortic valve disease is likely to continue to rise, given the expected evolution of the age pyramid.
There is no medical treatment able to slow down the degenerative process of the valve, and the only treatment is aortic valve replacement when the AS becomes constricted and the patient is eligible for an intervention. Aortic valve replacement has historically been performed surgically, with open-chest surgery to remove the damaged valve and replace it with a mechanical or biological valve prosthesis. Now Transcatheter Aortic Valve Implantation (TAVI) has replaced this procedure. This involves inserting a bioprosthesis crimped into a stent via an endovascular route, i.e. without opening the thorax. Deployment of the stent crushes the native valve, leaving the functional bioprosthesis in place.
Initially developed for patients contraindicated to surgery, TAVI is now offered as a first-line treatment for patients aged 75 and over.
Inexistent before 2010, the number of TAVIs equalled the number of surgeries by 2015, and TAVIs currently account for ¾ of aortic valve procedures (unpublished data).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poor prognosis patients | – | Other: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scorePatients will performed the Quality Of Life Questionnaire (EQ-5D-5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) at baseline (day of the TAVI procedure) and 2 months post-TAVI. The CAPRI score will be calculated from the data of the pre TAVI assessment at the end of study participation (12 months) and will determine the group of the patient. The higher the score, the worse the prognosis. |
| Intermediate prognosis patients | – | Other: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scorePatients will performed the Quality Of Life Questionnaire (EQ-5D-5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) at baseline (day of the TAVI procedure) and 2 months post-TAVI. The CAPRI score will be calculated from the data of the pre TAVI assessment at the end of study participation (12 months) and will determine the group of the patient. The higher the score, the worse the prognosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with indication of TAVI followed in four french cardiology department.
Key inclusion criteria (4 listed)
- Patients with symptomatic aortic stenosis (exertional dyspnea, angina, malaise/syncope)
Key exclusion criteria (7 listed)
- Patient refusing TAVI procedure
- CT scan not performed during the pre-TAVI assessment
- Patient unable to understand or answer quality-of-life questionnaires
- Pregnant or breast-feeding women
- Patients participating in other interventional research that may interfere with the present study with an exclusion period still in progress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scoreChange in quality-of-life score assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) between the 2-month early visit and inclusion in the poor-prognosis group. | Other | Intermediate prognosis patients, Poor prognosis patients |
Primary outcome
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score variation between the 2-months visit and inclusion.
Time frame: Day 0 and Month 2
Change in quality-of-life score assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) between the 2-month early visit and inclusion in the poor-prognosis group. The KCCQ-12 contains four subdomains: Physical Limitation, Symptom Frequency, Quality of Life, and Social Limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 the best possible health status
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 17 Jan 2025.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Stenosis, run by Hospices Civils de Lyon at 4 sites 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Pierre Lantelme, MD (04.72.07.25.36 ext. +33, pierre.lantelme@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score variation between the 2-months visit and inclusion. (time frame: Day 0 and Month 2). 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 17 Jan 2025.