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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04636684
Other study ID # RC31/19/0446
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2025

Study information

Verified date July 2023
Source University Hospital, Toulouse
Contact Magali COLOMBAT, MD
Phone 5 31 15 61 40
Email colombat.m@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Proteomic analysis
Proteomic analysis based on mass spectrometry on the sample of valve tissues.

Locations

Country Name City State
France university hospital center Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence rate of valvular ATTR amyloidosis calculation of the prevalence rate of valvular ATTR amyloidosis with its 95% confidence interval. 1 year
Secondary Prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy The prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy (HMDP scan) will be calculated 1 year
Secondary percentage of wild ATTR myocardial amyloidosis The percentage of wild ATTR forms will be calculated 1 year
Secondary percentage of mutated ATTR myocardial amyloidosis The percentage of mutated ATTR forms will be calculated 1 year
Secondary Prevalence of types of amyloidosis other than ATTR The prevalence of types of amyloidosis other than ATTR will be calculated 1 year
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