ClinicalTrials.gov record NCT06458374
ATTR Cardiac Amyloidosis in a Selected Population
Prevalence and Long Tem Follow up of ATTR Cardiac Amyloidosis in a Selected Population of Patients Operated on Carpal Tunnel Syndrome
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 prospective observational study screens people who had carpal tunnel surgery for ATTR amyloid in the removed tissue. Those with biopsy-proven ATTR will receive guideline-recommended heart testing and be followed at least yearly for up to 10 years. The study also excludes light-chain (AL) disease and may include up to 200 surgery patients.
What it is studying. The study is measuring how often ATTR amyloid is present in carpal tunnel surgery tissue and whether people with tissue-proven ATTR develop cardiac amyloidosis over a 10-year period.
What the researchers hope to learn. To measure the frequency of variant and wild-type ATTR in carpal tunnel surgery tissue and to document cardiac involvement and its course in biopsy-proven ATTR over 10 years.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Patients operated for carpal tunnel syndrome (CTS) at Ålesund Hospital (200 patients) will have a biopsy to diagnose ATTR amyloidosis. Patients with positive biopsy will be examined to decide wether they have cardiac amyloidosis. All patients with positive biopsy will be followed closely for 10 years wit echocardiography an clinically.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Male > 50 years
- Female > 60 years
- operated CTS at Ålesund Hospital
Exclusion criteria
- not consented
- do not speak Norwegian
- secondary cause of CTS as traumatic or rheumatic
- cannot be followed > 5 years due to other medical conditions
- Cardiac disease at time of operation for CTS
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
Biopsy proven ATTR (v/wt) amyloidosis inpatients operated with CTS will undergo standard guidelines recommended examinations as 99mTcDPD SPECT CT, echocardiography, ECG, Holter, genetic testing (v/wt), and lab testing, and CMRI as indicated. Exclusion of light chain disease will be done. All patients will be followed at least yearly as indicated by guidelines (ESC), and patients with development of cardiac amyloidosis will get standard treatment in accordance with guidelines and as approved by the Norwegian government. All patients will be followed for 10 years.
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.
Tissue removed at carpal tunnel surgery will be tested by biopsy for ATTR amyloid. People with a positive biopsy will have heart-focused tests such as a 99mTc‑DPD SPECT‑CT scan, echocardiography, ECG, Holter monitoring, and possibly cardiac MRI, plus genetic testing and blood tests to exclude light‑chain disease. All patients with a positive biopsy will be followed clinically and with echocardiography at least yearly and monitored for up to 10 years. If cardiac amyloidosis develops, participants will receive standard treatment according to guidelines.
How the study is structured. This is a prospective, observational, case-only study. Tissue from carpal tunnel surgery will be examined for ATTR amyloid. People with positive biopsies will undergo guideline-recommended cardiac tests (99mTcDPD SPECT CT, echocardiography, ECG, Holter, genetic testing for variant and wild-type ATTR, laboratory tests, and cardiac MRI when indicated), exclusion of light-chain disease, and yearly follow-up for up to 10 years. If cardiac amyloidosis develops, treatment will follow standard guidelines and local approvals.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under ATTR Amyloidosis Wild Type; ATTR Gene Mutation; Carpal Tunnel Syndrome; Cardiac Amyloidosis. Does it apply to my diagnosis?
- 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 Norway. 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
- Sep 1, 2024
- Primary completion
- Feb 28, 2034 (estimated)
- Study completion
- Feb 28, 2039 (estimated)
- Target enrollment
- 180 participants (estimated)
- Last updated on registry
- Aug 12, 2026
- 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
- Helse Møre og Romsdal HF
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.
- Torstein Hole, Professor, MD, PhD 📞 +4770105000, +4793421002 ✉ torstein.hole@helse-mr.no
- Jørn A Lillebø, consultant cardiology, MD 📞 +4770105000 ✉ jorn.asle.lillebo@helse-mr.no
Participating sites (1)
- Ålesund HospitalRecruiting
Ålesund, Møre og Romsdal, 6026 · Norway
- Torstein Hole, PhD · +4770105000 · torstein.hole@helse-mr.no
- Jørn A Lillebø, MD · +4770105000 · jorn.asle.lillebo@helse-mr.no
Terms used on this page · explanations by MedicalUpdates.ai
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- 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.
- CT
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- ECG
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- standard treatment
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
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.
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