Act on Quality of Life in Patients With aortIc Stenosis
ALPINIST
Act on Quality of Life in Poor Prognosis Aortic Stenosis Patients
1 other identifier
observational
240
1 country
4
Brief 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. 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number of TAVIs equalled the number of surgeries by 2015, and TAVIs currently account for ¾ of aortic valve procedures (unpublished data).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2024
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedStudy Start
First participant enrolled
December 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 19, 2027
January 17, 2025
January 1, 2025
3 years
June 18, 2024
January 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Day 0 and Month 2
Study Arms (2)
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.
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
Interventions
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.
Eligibility Criteria
Patient with indication of TAVI followed in four french cardiology department.
You may qualify if:
- 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
You may not qualify if:
- 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
- Persons under judicial protection
- Patients under guardianship, curators or safeguard of justice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Service de Cardiologie - CHU Clermont Ferrand
Clermont-Ferrand, 63000, France
Service de Cardiologie
Lille, 59000, France
Service de Cardiologie
Lyon, 69004, France
Service de Cardiologie - Institut Thorax Nantes
Nantes, 44000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2024
First Posted
June 27, 2024
Study Start
December 19, 2024
Primary Completion (Estimated)
December 19, 2027
Study Completion (Estimated)
December 19, 2027
Last Updated
January 17, 2025
Record last verified: 2025-01