NCT06713889 Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI
| NCT ID | NCT06713889 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2024-12-19 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Contact & Investigator
Ahmad HAYEK, MD
PRINCIPAL INVESTIGATOR
Plateau technique interventionnel - Hôpital Louis Pradel, GHE
Frequently Asked Questions
Who can join the NCT06713889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06713889 currently recruiting?
Yes, NCT06713889 is actively recruiting participants. Contact the research team at ahmad.hayek@chu-lyon.fr for enrollment information.
Where is the NCT06713889 trial being conducted?
This trial is being conducted at Lyon, France, Lyon, France.
Who is sponsoring the NCT06713889 clinical trial?
NCT06713889 is sponsored by Hospices Civils de Lyon. The principal investigator is Ahmad HAYEK, MD at Plateau technique interventionnel - Hôpital Louis Pradel, GHE. The trial plans to enroll 125 participants.