ClinicalTrials.gov record NCT06907836
Description of a Retrospective Cohort of Patients With Transthyretin Cardiac Amyloidosis (ATTR-CA) in Internal Medicine
Description of a Retrospective Cohort of Patients With Transthyretin Cardiac Amyloidosis (ATTR-CA) in Internal Medicine
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This retrospective observational study reviews medical records of adults with transthyretin (TTR) cardiac amyloidosis who were seen in internal medicine between 01/01/2013 and 12/31/2023. Its main aim is to describe how many such cases were referred to internal medicine during that period. The study uses existing records (case-only) and does not test any treatments or procedures on participants.
What it is studying. The study is collecting and reviewing past medical records to describe the number of transthyretin (TTR) cardiac amyloidosis cases seen in internal medicine between 2013 and 2023.
What the researchers hope to learn. To document the number of transthyretin (TTR) cardiac amyloidosis cases referred to internal medicine at the site during 2013–2023 and to better describe the condition's representation in internal medicine records.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a retrospective review of past medical records from the qualifying internal-medicine hospitalizations to identify and describe cases of TTR cardiac amyloidosis. The registry does not list any new visits, tests, procedures, or sample collection for participants. People who have formally objected to reuse of their data will be excluded. The record does not state whether participants will be contacted.
How the study is structured. A retrospective, observational review of medical records (case-only). Researchers will analyze existing charts from the specified 2013–2023 timeframe; no new tests or treatments are assigned.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
This trial is also listed on this site under ATTRv amyloidosis.
Important dates
- Study start
- Apr 22, 2024
- Primary completion
- Dec 22, 2025 (estimated)
- Study completion
- Dec 22, 2025 (estimated)
- Target enrollment
- 30 participants (estimated)
- Last updated on registry
- Apr 2, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University Hospital, Strasbourg, France
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Emmanuel ANDRES, MD, PhD 📞 33 3 88 12 71 33 ✉ emmanuel.andres@chru-strasbourg.fr
Participating sites (1)
- Service de Médecine Interne - CHU de Strasbourg - FranceRecruiting
Strasbourg, 67091 · France
- Emmanuel ANDRES, MD, PhD · 33 3 88 12 71 33 · emmanuel.andres@chru-strasbourg.fr
- Emmanuel ANDRES, MD, PhD
- Xavier JANNOT, MD
- Nöel LORENZO, MD
- Clara BARHOUMI, Statistician
- François SEVERAC, Statistician
Terms used on this page · explanations by MedicalUpdates.ai
- natural history
- A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
- legal representative
- A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials