Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI (Bio-TAVI)

Aortic stenosis, a common cardiovascular disease, is pathophysiologically associated with a chronic inflammatory myocardial reaction and fibrosis leading to cardiac dysfunction and impaired coronary perfusion. These elements may precede the onset of symptoms. The assessment of inflammatory and fibrosis factors (in particular by means of biomarkers) in patients with aortic stenosis will make it possible to identify asymptomatic patients at greater risk who could benefit from intervention earlier. This is part of a personalised medicine adapted to the patient.

Patients will be recruited during their TAVI (Transcatheter Aortic Valve Implantation) assessment consultation. If the patient agrees to take part in the study, information relating to routine care procedures will be collected (patient history, clinical examinations, electrocardiogram, echography, coronary angiography, TAVI procedure if applicable, biology).

Outside of routine care, a biocollection will be established (serum, plasma), quality of life questionnaires will be carried out and adverse events will be collected where present.

Patients will be divided into 3 groups according to the indication for TAVI (Group A - symptomatic severe aortic stenosis with indication for TAVI, Group B - asymptomatic severe aortic stenosis without indication for TAVI, Group C - asymptomatic moderate aortic stenosis without indication for TAVI).

The main objective is to compare the levels of biomarkers of inflammation and fibrosis between the 3 groups at each sampling time common to all three groups between inclusion and 1-year follow-up.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Behavioral: Quality of life questionnaires; Biological: Biocollection

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Yvonne VARILLON; Phone Number: +33 4 72 35 69 64; Email: yvonne.varillon@chu-lyon.fr
• Study Contact Backup: Name: Ahmad HAYEK, MD; Phone Number: +33 4 72 35 72 80; Email: ahmad.hayek@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69500
    • Recruiting
    • Hospices Civils de Lyon - Hopital Louis Pradel
    • Contact: Ahmad HAYEK, MD; Phone Number: +33 04 72 35 72 80; Email: ahmad.hayek@chu-lyon.fr
    • Principal Investigator: Ahmad HAYEK, MD
  • Lyon, France, 69004
    • Recruiting
    • Hospices Civils de Lyon - Hôpital Croix Rousse
    • Contact: Brahim Harbaoui, Prof; Phone Number: +33 04 72 35 58 25; Email: brahim.harbaoui@chu-lyon.fr
    • Principal Investigator: Brahim Harbaoui, Prof

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

125 patients will be selected from among those seen in consultation for aortic stenosis assessment in the cardiology departments of the Louis Pradel and Croix-Rousse hospitals.

Description

Inclusion Criteria:

• Patients >=18 years of age
• Patient with symptomatic or asymptomatic severe or moderately severe aortic stenosis (according to the recommendations of the European Society of Cardiology - ESC).
• No opposition.

Exclusion Criteria:

• Conjunctive heart disease (e.g. amyloidosis).
• Presence of a contraindication to TAVI.
• Impossibility of giving the subject informed information.
• Privation of civil rights (curatorship, tutorship, protection of justice).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Patients with symptomatic severe aortic stenosis, with indication for TAVI. They are followed at inclusion, during hospitalisation of the TAVI procedure, at 1-month follow-up, at 1-year follow-up and by phone at 2 years follow-up.	Behavioral: Quality of life questionnaires; EQ-5D-5L and HAD questionnaire at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up; Biological: Biocollection; At each sampling time, 2 dry tubes of 4 ml, 1 EDTA tube of 4 ml, and 1 heparinised tube of 4 ml, i.e. a total of 16 ml per sampling time. Group A patients will be sampled at inclusion (or before the TAVI procedure), during and after the TAVI procedure, at 1 month follow-up and at 1 year follow-up, for a total of 120 ml. Patients in groups B and C will be sampled at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up, for a total of 80 ml.
Group B; Patients with asymptomatic severe aortic stenosis, without indication for TAVI. They are followed at inclusion, at 1-month follow-up, at 1-year follow-up and at 2 years follow-up.	Behavioral: Quality of life questionnaires; EQ-5D-5L and HAD questionnaire at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up; Biological: Biocollection; At each sampling time, 2 dry tubes of 4 ml, 1 EDTA tube of 4 ml, and 1 heparinised tube of 4 ml, i.e. a total of 16 ml per sampling time. Group A patients will be sampled at inclusion (or before the TAVI procedure), during and after the TAVI procedure, at 1 month follow-up and at 1 year follow-up, for a total of 120 ml. Patients in groups B and C will be sampled at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up, for a total of 80 ml.
Group C; Patients with asymptomatic middle aortic stenosis, without indication for TAVI. They are followed at inclusion, at 1-month follow-up, at 1-year follow-up and at 2 years follow-up.	Behavioral: Quality of life questionnaires; EQ-5D-5L and HAD questionnaire at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up; Biological: Biocollection; At each sampling time, 2 dry tubes of 4 ml, 1 EDTA tube of 4 ml, and 1 heparinised tube of 4 ml, i.e. a total of 16 ml per sampling time. Group A patients will be sampled at inclusion (or before the TAVI procedure), during and after the TAVI procedure, at 1 month follow-up and at 1 year follow-up, for a total of 120 ml. Patients in groups B and C will be sampled at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up, for a total of 80 ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing biomarkers	The primary endpoint is the level of biomarkers of inflammation and fibrosis in the 3 groups of patients.	At V0 (inclusion), V4 (1-month follow up) and V5 (1-year follow up).

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Ahmad HAYEK, MD, Plateau technique interventionnel - Hôpital Louis Pradel, GHE

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Biomarkers; TAVI; Aortic stenosis; Cardiology
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 69HCL21_1209; 2024-A01552-45 (Other Identifier: ID-RCB)

Drug and device information, study documents

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