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

NCT04636684 | Recruiting

• 1 other identifier: RC31/19/0446
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloidosis

Keywords

ATTR aortic valve amyloidosis

Outcome Measures

Primary Outcomes (1)

• prevalence rate of valvular ATTR amyloidosis

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

  1 year

Secondary Outcomes (4)

• Prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy

  1 year

• percentage of wild ATTR myocardial amyloidosis

  1 year

• percentage of mutated ATTR myocardial amyloidosis

  1 year

• Prevalence of types of amyloidosis other than ATTR

  1 year

Study Arms (1)

patients undergoing surgical valve replacement for degenerative aortic stenosis

EXPERIMENTAL

Diagnostic Test: Proteomic analysis

Interventions

Proteomic analysis DIAGNOSTIC_TEST

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

patients undergoing surgical valve replacement for degenerative aortic stenosis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

university hospital center Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Magali COLOMBAT, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magali COLOMBAT, MD

CONTACT

5 31 15 61 40; colombat.m@chu-toulouse.fr

Olivier LAIREZ, MD

CONTACT

5 61 32 28 73; lairez.o@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

FR (1)