Investigating the role of ATTR amyloidosis in patients with aortic stenosis
Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis
This study is trying to see how common a specific type of amyloidosis is in patients with aortic stenosis who are having valve replacement surgery, to better understand its impact on their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT04636684 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the prevalence and significance of ATTR aortic valve amyloidosis in patients undergoing aortic valve replacement surgery for degenerative aortic stenosis. It will utilize proteomic analysis to identify amyloid deposits in the aortic valve, which have previously been overlooked due to negative immunostaining results. By understanding the presence and implications of these deposits, the study seeks to clarify their clinical relevance in the context of cardiac amyloidosis. The findings could potentially reshape the understanding of degenerative aortic stenosis and its association with amyloidosis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with degenerative aortic stenosis and are scheduled for aortic valve replacement surgery.
Not a fit: Patients with non-degenerative aortic stenosis, such as those with bicuspid valves or rheumatic disease, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients with aortic stenosis and underlying amyloidosis.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated a significant prevalence of ATTR cardiac amyloidosis in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years old * Degenerative aortic stenosis * Aortic valve replacement surgery * Signature of the informed consent form Exclusion Criteria: * Non-degenerative aortic stenosis: bicuspid, rheumatic disease, aortic regurgitation * Persons under a system of legal protection for adults (guardianship, curatorship, etc.) * Pregnant women
Where this trial is running
Toulouse
- university hospital center Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Magali COLOMBAT, MD — University Hospital, Toulouse
- Study coordinator: Magali COLOMBAT, MD
- Email: colombat.m@chu-toulouse.fr
- Phone: 5 31 15 61 40
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.