Clinical trial NCT06713889: Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI
Official title: Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Keywords: Aortic stenosis
TAVI
Cardiology
Biomarkers
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Comparing biomarkers
timeFrame: At V0 (inclusion), V4 (1-month follow up) and V5 (1-year follow up).
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital Croix Rousse
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital Louis Pradel
Study officials:
affiliation: Plateau technique interventionnel - Hôpital Louis Pradel, GHE
name: Ahmad HAYEK, MD
role: PRINCIPAL_INVESTIGATOR
References: