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

Not Applicable

Recruiting

• Conditions: Amyloidosis
• Interventions: Diagnostic Test: Proteomic analysis

• Registration Number: NCT04636684
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-19
• Study Start: 2020-12-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients undergoing surgical valve replacement for degenerative aortic stenosis	Proteomic analysis	-

Primary Outcome Measures

Name	Time	Method
prevalence rate of valvular ATTR amyloidosis	1 year	calculation of the prevalence rate of valvular ATTR amyloidosis with its 95% confidence interval.

Secondary Outcome Measures

Name	Time	Method
percentage of wild ATTR myocardial amyloidosis	1 year	The percentage of wild ATTR forms will be calculated
Prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy	1 year	The prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy (HMDP scan) will be calculated
percentage of mutated ATTR myocardial amyloidosis	1 year	The percentage of mutated ATTR forms will be calculated
Prevalence of types of amyloidosis other than ATTR	1 year	The prevalence of types of amyloidosis other than ATTR will be calculated

Trial Locations

Locations (1)

university hospital center Toulouse; 🇫🇷 Toulouse, France