Act on Quality of Life in Patients With aortIc Stenosis (ALPINIST)

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.

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number of TAVIs equalled the number of surgeries by 2015, and TAVIs currently account for ¾ of aortic valve procedures (unpublished data).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 Overview

• Status: Recruiting
• Conditions: Severe Aortic Stenosis
• Intervention / Treatment: Other: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Julia CANTERINI; Phone Number: +33 04 27 85 66 28; Email: julia.canterini@chu-lyon.fr
• Study Contact Backup: Name: Pierre Lantelme, MD; Phone Number: +33 04.72.07.25.36; Email: pierre.lantelme@chu-lyon.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Not yet recruiting
    • Service de Cardiologie - CHU Clermont Ferrand
    • Contact: Géraud Souteyrand, MD; Phone Number: +33 04737513; Email: gsouteyrand@chu-clermontferrand.fr
    • Principal Investigator: Géraud Souteyrand, MD
  • Lille, France, 59000
    • Not yet recruiting
    • Service de Cardiologie
    • Principal Investigator: Eric Van Belle, MD
    • Contact: Eric VAN BELLE, MD; Phone Number: +33 032045962; Email: ericvanbelle@aol.com
  • Lyon, France, 69004
    • Recruiting
    • Service de Cardiologie
    • Contact: Julia CANTERINI; Phone Number: +33 04 27 85 66 28; Email: julia.canterini@chu-lyon.fr
    • Contact: Pierre Lantelme, MD; Phone Number: +33 0472072536; Email: pierre.lantelme@chu-lyon.fr
  • Nantes, France, 44000
    • Not yet recruiting
    • Service de Cardiologie - Institut Thorax Nantes
    • Contact: Thibaut Manigold, MD; Phone Number: +33 0253482772; Email: thibaut.manigold@chu-nantes.fr
    • Principal Investigator: Thibaut Manigold, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with indication of TAVI followed in four french cardiology department.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score; 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.
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	Other: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): December 19, 2027
• Study Completion (Estimated): December 19, 2027

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; Aortic Stenosis; TAVI
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 69HCL22_0930

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No