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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological, Behavioral
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hospices Civils de Lyon - Hôpital Croix Rousse
NOT_YET_RECRUITING
Lyon
Hospices Civils de Lyon - Hôpital Louis Pradel
RECRUITING
Lyon
Contact Information
Primary
Ahmad HAYEK, MD
ahmad.hayek@chu-lyon.fr
4 72 35 72 80
Backup
Yvonne VARILLON
yvonne.varillon@chu-lyon.fr
4 72 35 69 64
Time Frame
Start Date: 2024-12-19
Estimated Completion Date: 2028-06
Participants
Target number of participants: 125
Treatments
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.
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.
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.
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov