Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proteomic analysis.
- Who it may be relevant to
- Registry conditions: Amyloidosis. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Proteomic analysis
Proteomic analysis based on mass spectrometry on the sample of valve tissues.
Primary outcome measures
- prevalence rate of valvular ATTR amyloidosis [Time frame: 1 year]
Secondary outcome measures (4)
- Prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy [Time frame: 1 year]
- percentage of wild ATTR myocardial amyloidosis [Time frame: 1 year]
- percentage of mutated ATTR myocardial amyloidosis [Time frame: 1 year]
- Prevalence of types of amyloidosis other than ATTR [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- university hospital center Toulouse — Toulouse
Identifiers
NCT: NCT04636684 · RC31/19/0446