Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI
ConditionAortic Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biocollection
Biological/VaccineAt 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.
Quality of life questionnaires
BehavioralEQ-5D-5L and HAD questionnaire at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up
Treatment groups
125 Participants
are divided into 3 treatment groupsGroup A: Group A2 interventions
Group B: Group B2 interventions
Group C: Group C2 interventions
Trial outcomes
Primary outcomes
1
Comparing biomarkers
The primary endpoint is the level of biomarkers of inflammation and fibrosis in the 3 groups of patients.
Time frame
At V0 (inclusion), V4 (1-month follow up) and V5 (1-year follow up).Sponsors and contacts
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Source ClinicalTrials.gov