ClinicalTrials.gov record NCT06458374

ATTR Cardiac Amyloidosis in a Selected Population

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

Prevalence and Long Tem Follow up of ATTR Cardiac Amyloidosis in a Selected Population of Patients Operated on Carpal Tunnel Syndrome

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age50 years old and older
SexAll
LocationNorway
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 looks for ATTR amyloidosis in people who had carpal tunnel surgery at Ålesund Hospital. A biopsy taken at surgery will be used to diagnose ATTR; people with a positive biopsy will be examined for heart involvement using imaging and heart tests. Biopsy-positive participants will be followed with clinical exams and echocardiography (and other guideline-recommended tests) for up to 10 years.

What it is studying. The study is testing how often ATTR amyloid is present in patients operated for carpal tunnel syndrome and how frequently and when cardiac involvement appears over long-term follow-up.

What the researchers hope to learn. To determine the frequency of ATTR amyloid in patients with carpal tunnel syndrome. To describe how often and when cardiac amyloidosis develops in those with biopsy-proven ATTR during long-term follow-up.

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.

Participants will have a tissue biopsy checked for ATTR amyloid. Those with biopsy-proven ATTR will undergo heart-focused testing such as 99mTc‑DPD SPECT‑CT, echocardiography, ECG, Holter monitoring, genetic testing for variant/wild‑type ATTR, laboratory testing including exclusion of light‑chain (AL) disease, and cardiac MRI when indicated. All participants with a positive biopsy will be followed clinically, with at least yearly visits and echocardiography, for up to 10 years. If cardiac amyloidosis develops, treatment will be given according to clinical guidelines and national approvals.

How the study is structured. This is a prospective, case-only observational study. Patients operated for carpal tunnel syndrome will have a biopsy to check for ATTR amyloid. Those with biopsy-proven ATTR will undergo guideline-recommended heart evaluations (for example, 99mTc-DPD SPECT/CT, echocardiography, ECG, Holter monitoring, genetic testing, laboratory tests, and cardiac MRI if indicated) and will be followed clinically at least yearly for up to 10 years.

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 ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

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.

Participating sites (1)

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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