Identifying biomarkers for cardiovascular events in aortic stenosis patients
Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI
This study is trying to find biological markers that can help identify aortic stenosis patients at risk for heart problems, especially those getting a new heart valve, so they can get treatment sooner.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Lyon and 1 other locations) |
| Trial ID | NCT06713889 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify biological markers associated with cardiovascular events in patients suffering from aortic stenosis, particularly those undergoing Transcatheter Aortic Valve Implantation (TAVI). By assessing inflammatory and fibrosis factors through biomarkers, the study seeks to pinpoint asymptomatic patients at higher risk for earlier intervention. Patients will be recruited during their TAVI assessment consultations, and data will be collected from routine care procedures along with a biocollection of serum and plasma samples. Quality of life questionnaires will also be administered to gather comprehensive patient information.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with symptomatic or asymptomatic severe or moderately severe aortic stenosis.
Not a fit: Patients with contraindications to TAVI or those with other significant heart diseases like amyloidosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable earlier interventions for high-risk aortic stenosis patients, potentially improving their outcomes.
How similar studies have performed: Other studies have explored biomarkers in cardiovascular diseases, suggesting potential for success in this approach, though this specific focus on aortic stenosis is less common.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Lyon and 1 other locations
- Hospices Civils de Lyon - Hôpital Croix Rousse — Lyon, France (Recruiting)
- Hospices Civils de Lyon - Hôpital Louis Pradel — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Ahmad HAYEK, MD — Plateau technique interventionnel - Hôpital Louis Pradel, GHE
- Study coordinator: Ahmad HAYEK, MD
- Email: ahmad.hayek@chu-lyon.fr
- Phone: 4 72 35 72 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.