Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI

NCT06713889 | Recruiting

• 2 other identifiers: 69HCL21_12092024-A01552-45
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Aortic Stenosis

Keywords

Aortic stenosis; TAVI; Cardiology; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (3)

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.

Biological: Biocollection; Behavioral: Quality of life questionnaires

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.

Biological: Biocollection; Behavioral: Quality of life questionnaires

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.

Biological: Biocollection; Behavioral: Quality of life questionnaires

Interventions

Biocollection BIOLOGICAL

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, before, 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 A; Group B; Group C

Quality of life questionnaires BEHAVIORAL

EQ-5D-5L and HAD questionnaire at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hospices Civils de Lyon - Hôpital Croix Rousse

Lyon, 69004, France

RECRUITING

Hospices Civils de Lyon - Hôpital Louis Pradel

Lyon, 69500, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

In order to build up the cohort's biocollection (serotheque, plasmatheque), additional tubes will be taken at the same time as routine blood sampling. 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, before, 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.

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Ahmad HAYEK, MD

  Plateau technique interventionnel - Hôpital Louis Pradel, GHE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad HAYEK, MD

CONTACT

4 72 35 72 80; ahmad.hayek@chu-lyon.fr

Yvonne VARILLON

CONTACT

4 72 35 69 64; yvonne.varillon@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-10

Locations

FR (2)