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NCT Number: NCT04636684

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

university hospital center Toulouse

Toulouse, France

Location status: Recruiting

Location contact

Audrey TOMASIK

CONTACT

[email protected]

5 61 77 85 97 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proteomic analysis

Diagnostic Test

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

Primary outcomes

  1. 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

  1. Prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy

    Time frame: 1 year

    The prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy (HMDP scan) will be calculated

  2. percentage of wild ATTR myocardial amyloidosis

    Time frame: 1 year

    The percentage of wild ATTR forms will be calculated

  3. percentage of mutated ATTR myocardial amyloidosis

    Time frame: 1 year

    The percentage of mutated ATTR forms will be calculated

  4. Prevalence of types of amyloidosis other than ATTR

    Time frame: 1 year

    The prevalence of types of amyloidosis other than ATTR will be calculated

Study contacts

Contact information is provided by the study sponsor or research team.

Magali COLOMBAT, MD

CONTACT

[email protected]

5 31 15 61 40 ext. +33

Olivier LAIREZ, MD

CONTACT

[email protected]

5 61 32 28 73 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: RACAMYL

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Nov 19, 2020
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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