Cardiac AmyloidosisATTR-CANCT06907836
Description of a Retrospective Cohort of Patients With Transthyretin Cardiac Amyloidosis (ATTR-CA) in Internal Medicine
An observational study of Cardiac Amyloidosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
In 2024, the prevalence of TTR cardiac amyloidosis is difficult to determine precisely. Indeed, the disease has long been underdiagnosed due to a lack of effective treatment and non-invasive diagnostic methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2024to 22 Dec 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sujet majeur (≥18 ans) avec un diagnostic d'amylose à TTR
Who may be able to join
- Sujet majeur (≥18 ans)
- Diagnostic d'amylose à TTR suite à une hospitalisation en médecine interne aux HUS entre 01/01/2013 au 31/12/2023.
Who cannot join
- Subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes.
- Type of amyloidosis other than ATTR after review of the medical record (immunological assessment, imaging assessment, expert report).
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
Service de Médecine Interne - CHU de Strasbourg - France
Strasbourg, 67091
Emmanuel ANDRES, MD, PhD, 33 3 88 12 71 33, emmanuel.andres@chru-strasbourg.fr
Emmanuel ANDRES, MD, PhD
About this study
In 2024, the prevalence of TTR cardiac amyloidosis is difficult to determine precisely. Indeed, the disease has long been underdiagnosed due to a lack of effective treatment and non-invasive diagnostic methods. The prevalence of ATTRwt is estimated at 155 to 191 cases per million person-years, with an incidence of 36 cases per million person-years. Both incidence and prevalence increase with age.
The most common presentation of TTR cardiac amyloidosis is heart failure with preserved ventricular ejection fraction (LVEF).
Read more
The natural history of TTR cardiac amyloidosis is progression to restrictive heart disease with all the complications described above.
The median time between diagnosis and the first cardiac symptoms was 39 months. Currently, the median survival in France is approximately 3.5 years, but survival appears to be improving, with a mortality rate of 73.5% at 30 months between 2002 and 2006, compared to 15% at 60 months between 2017 and 2022.
The number of patients diagnosed with TTR cardiac amyloidosis appears to be increasing. The overwhelming majority of available data concerns patients treated in cardiology. However, the issue of TTR cardiac amyloidosis concerns all specialists caring for patients with heart failure, particularly in internal medicine due to the high number of admissions from emergency departments, with a significant proportion of patients suffering from cardiac decompensation.
- Conditions
- Cardiac Amyloidosis
- Keywords
- Cardiac Amyloidosis, Internal medicine
- Medical subject headings
- Amyloid Neuropathies, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the number of cases of transthyretin (TTR) cardiac amyloidosis referred to internal medicine between 2013 and 2023.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start22 Apr 2024
- Primary completion22 Dec 2025 (estimated)
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907836
- Sponsor's protocol ID
- 9302
- Acronym
- ATTR-CA
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- 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 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of a Retrospective Cohort of Patients With Transthyretin Cardiac Amyloidosis (ATTR-CA) in Internal Medicine
- ClinicalTrials.gov ID
- NCT06907836
- Acronym / sponsor ID
- ATTR-CA / 9302
- Conditions
- Cardiac Amyloidosis
- Keywords
- Cardiac Amyloidosis, Internal medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 2 Apr 2025 (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.
In 2024, the prevalence of TTR cardiac amyloidosis is difficult to determine precisely. Indeed, the disease has long been underdiagnosed due to a lack of effective treatment and non-invasive diagnostic methods. The prevalence of ATTRwt is estimated at 155 to 191 cases per million person-years, with an incidence of 36 cases per million person-years. Both incidence and prevalence increase with age.
The most common presentation of TTR cardiac amyloidosis is heart failure with preserved ventricular ejection fraction (LVEF).
The natural history of TTR cardiac amyloidosis is progression to restrictive heart disease with all the complications described above.
The median time between diagnosis and the first cardiac symptoms was 39 months. Currently, the median survival in France is approximately 3.5 years, but survival appears to be improving, with a mortality rate of 73.5% at 30 months between 2002 and 2006, compared to 15% at 60 months between 2017 and 2022.
The number of patients diagnosed with TTR cardiac amyloidosis appears to be increasing. The overwhelming majority of available data concerns patients treated in cardiology. However, the issue of TTR cardiac amyloidosis concerns all specialists caring for patients with heart failure, particularly in internal medicine due to the high number of admissions from emergency departments, with a significant proportion of patients suffering from cardiac decompensation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sujet majeur (≥18 ans) avec un diagnostic d'amylose à TTR
Key inclusion criteria (2 listed)
- Sujet majeur (≥18 ans)
- Diagnostic d'amylose à TTR suite à une hospitalisation en médecine interne aux HUS entre 01/01/2013 au 31/12/2023.
Key exclusion criteria (2 listed)
- Subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes.
- Type of amyloidosis other than ATTR after review of the medical record (immunological assessment, imaging assessment, expert report).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe the number of cases of transthyretin (TTR) cardiac amyloidosis referred to internal medicine between 2013 and 2023.
Time frame: Up to 10 years
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 2 Apr 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Amyloidosis, run by University Hospital, Strasbourg, France 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 2 inclusion and 2 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 2 Apr 2025. 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 Emmanuel ANDRES, MD, PhD (33 3 88 12 71 33, emmanuel.andres@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the number of cases of transthyretin (TTR) cardiac amyloidosis referred to internal medicine between 2013 and 2023. (time frame: Up to 10 years). 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 2 Apr 2025.