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Checks aortic valve tissue for transthyretin amyloid deposits in aortic stenosis

Tests valve tissue from adults having surgery for narrowed aortic valves.

Key facts

Who runs it
University Hospital, Toulouse
Where
Toulouse, FranceSee the site
Trial code
Registry title
Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis
Status
Recruiting
People taking part
100 people, planned
Started
1 Dec 2020
Expected to end
31 Dec 2027
Type of study
Interventional
Treatments tested
  • Proteomic analysis
Record updated
1 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with degenerative aortic stenosis who are having their aortic valve replaced by surgery. It studies amyloid deposits in the removed valve.

Age
Over 18 years old (up to 99 years).
Sex
Men and women can join.
Disease stage
Degenerative aortic stenosis, treated with aortic valve replacement surgery.

Main reasons for not taking part

  • Aortic stenosis that is not degenerative: bicuspid valve, rheumatic disease, aortic regurgitation
  • People under a legal protection system for adults (guardianship, curatorship, etc.)
  • Pregnant women

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Patient over 18 years old
  • Degenerative aortic stenosis
  • Aortic valve replacement surgery
  • Signature of the informed consent form

Who cannot take part

  • Non-degenerative aortic stenosis: bicuspid, rheumatic disease, aortic regurgitation
  • Persons under a system of legal protection for adults (guardianship, curatorship, etc.)
  • Pregnant women

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 99 years old?

Where in France

  • university hospital center ToulouseToulouse, FranceContact: Audrey TOMASIKTaking people

About the trial

What the trial wants to find out

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%.

Read full original descriptionShow less

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.

The group in the trial

  • patients undergoing surgical valve replacement for degenerative aortic stenosisTreatment being tested

    Treatment: Proteomic analysis

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis
Plain-language title
Checks aortic valve tissue for transthyretin amyloid deposits in aortic stenosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04636684, who can take part
Record updated
1 June 2026