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Clinical Trials/NCT04636684
NCT04636684
Recruiting
Not Applicable

Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis

University Hospital, Toulouse1 site in 1 country100 target enrollmentDecember 1, 2020
ConditionsAmyloidosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amyloidosis
Sponsor
University Hospital, Toulouse
Enrollment
100
Locations
1
Primary Endpoint
prevalence rate of valvular ATTR amyloidosis
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

prevalence rate of valvular ATTR amyloidosis

Time Frame: 1 year

calculation of the prevalence rate of valvular ATTR amyloidosis with its 95% confidence interval.

Secondary Outcomes

  • percentage of wild ATTR myocardial amyloidosis(1 year)
  • Prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy(1 year)
  • percentage of mutated ATTR myocardial amyloidosis(1 year)
  • Prevalence of types of amyloidosis other than ATTR(1 year)

Study Sites (1)

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