NCT04636684 Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis
| NCT ID | NCT04636684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-12-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2020-12-01 with a primary completion date of 2027-12-31.
⚠ 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
Cardiac amyloidosis is a restrictive cardiomyopathy with a potentially severe prognosis that can be life-threatening. It is linked in the vast majority of cases to a light chain deposition of immunoglobulin or transthyretin. Although myocardial involvement is predominant, other locations are possible: the atrioventricular conduction system, coronary arteries and valve leaflets. In systematic histological analyzes, deposits of amyloidosis infiltrating the aortic valve have been reported with a frequency of up to 74% for degenerative RA. The nature of these deposits has never been established because the immunostaining carried out all remained negative, probably due to decalcification prior to cutting. Currently, these deposits are considered to be local degenerative phenomena without clinical repercussions. However, the use of bone scintigraphy has shown a high prevalence, between 14 and 16%, of ATTR cardiac amyloidosis in patients with severe RA. The diagnosis of ATTR amyloidosis has been proven histologically in a few patients. Sequencing of the TTR gene has shown that they are mainly wild forms. In fact, the prevalence of transthyretin mutations in our local cohort is 20%. The objective of this study is to determine by proteomic analysis based on mass spectrometry, the prevalence of ATTR aortic valve amyloidosis in patients undergoing surgical valve replacement for degenerative aortic stenosis.
Eligibility 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
Contact & Investigator
Magali COLOMBAT, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT04636684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04636684 currently recruiting?
Yes, NCT04636684 is actively recruiting participants. Contact the research team at colombat.m@chu-toulouse.fr for enrollment information.
Where is the NCT04636684 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT04636684 clinical trial?
NCT04636684 is sponsored by University Hospital, Toulouse. The principal investigator is Magali COLOMBAT, MD at University Hospital, Toulouse. The trial plans to enroll 100 participants.