AmyloidosisRACAMYLNCT04636684
Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis
A study testing Proteomic analysis in people with Amyloidosis, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Amyloidosis
- What is being tested?
- Proteomic analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- Degenerative aortic stenosis
- Aortic valve replacement surgery
- Signature of the informed consent form
Who cannot join
- Non-degenerative aortic stenosis: bicuspid, rheumatic disease, aortic regurgitation
- Persons under a system of legal protection for adults (guardianship, curatorship, etc.)
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
university hospital center Toulouse
Toulouse
Audrey TOMASIK, 5 61 77 85 97 ext. +33, tomasik.a@chu-toulouse.fr
About this study
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
- Being tested
- Proteomic analysis
- Keywords
- ATTR aortic valve amyloidosis
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteomic analysisDiagnostic test
Proteomic analysis based on mass spectrometry on the sample of valve tissues.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing surgical valve replacement for degenerative aortic stenosis | Experimental | Not described Receives: Diagnostic Test: Proteomic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence rate of valvular ATTR amyloidosis
calculation of the prevalence rate of valvular ATTR amyloidosis with its 95% confidence interval.
Measured: 1 year
Secondary outcomes (4)
Prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy
The prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy (HMDP scan) will be calculated
Measured: 1 year
percentage of wild ATTR myocardial amyloidosis
The percentage of wild ATTR forms will be calculated
Measured: 1 year
percentage of mutated ATTR myocardial amyloidosis
The percentage of mutated ATTR forms will be calculated
Measured: 1 year
Prevalence of types of amyloidosis other than ATTR
The prevalence of types of amyloidosis other than ATTR will be calculated
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Dec 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magali COLOMBAT, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636684
- Sponsor's protocol ID
- RC31/19/0446
- Acronym
- RACAMYL
- Status last verified
- May 2026
- First submitted
- 13 Nov 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04636684
- Acronym / sponsor ID
- RACAMYL / RC31/19/0446
- Conditions
- Amyloidosis
- Keywords
- ATTR aortic valve amyloidosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing surgical valve replacement for degenerative aortic stenosis | Experimental | Diagnostic Test: Proteomic analysis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years old
- Degenerative aortic stenosis
- Aortic valve replacement surgery
- Signature of the informed consent form
Key exclusion criteria (3 listed)
- Non-degenerative aortic stenosis: bicuspid, rheumatic disease, aortic regurgitation
- Persons under a system of legal protection for adults (guardianship, curatorship, etc.)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteomic analysisProteomic analysis based on mass spectrometry on the sample of valve tissues. | Diagnostic test | patients undergoing surgical valve replacement for degenerative aortic stenosis |
Primary outcome
prevalence rate of valvular ATTR amyloidosis
Time frame: 1 year
calculation of the prevalence rate of valvular ATTR amyloidosis with its 95% confidence interval.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magali COLOMBAT, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proteomic analysis in people with Amyloidosis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali COLOMBAT, MD (5 31 15 61 40 ext. +33, colombat.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence rate of valvular ATTR amyloidosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.