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

Recruiting

• Conditions: Aortic Stenosis
• Interventions: Biological: Biocollection; Behavioral: Quality of life questionnaires

• Registration Number: NCT06713889
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-03
• Study Start: 2024-12-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2027-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Biocollection	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.
Group A	Quality of life questionnaires	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.
Group B	Biocollection	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.
Group B	Quality of life questionnaires	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.
Group C	Biocollection	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.
Group C	Quality of life questionnaires	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.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Hospices Civils de Lyon - Hôpital Croix Rousse; 🇫🇷 Lyon, France

Hospices Civils de Lyon - Hôpital Louis Pradel; 🇫🇷 Lyon, France