ATTR Amyloidosis Wild TypeNCT06458374
ATTR Cardiac Amyloidosis in a Selected Population
An observational study of ATTR Amyloidosis Wild Type and ATTR Gene Mutation, run by Helse Møre og Romsdal HF at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- ATTR Amyloidosis Wild Type, ATTR Gene Mutation, Carpal Tunnel Syndrome
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2024to 28 Feb 2039
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Maximum 200 patients operated at Ålesund Hospital for CTS
Who may be able to join
- Male > 50 years
- Female > 60 years
- operated CTS at Ålesund Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Ålesund Hospital
Ålesund, Møre og Romsdal, 6026
Torstein Hole, PhD, +4770105000, torstein.hole@helse-mr.no
Jørn A Lillebø, MD, +4770105000, jorn.asle.lillebo@helse-mr.no
About this study
Official title: Prevalence and Long Tem Follow up of ATTR Cardiac Amyloidosis in a Selected Population of Patients Operated on Carpal Tunnel Syndrome
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.
Read the detailed description
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.
- Conditions
- ATTR Amyloidosis Wild Type, ATTR Gene Mutation, Carpal Tunnel Syndrome, Cardiac Amyloidosis
- Medical subject headings
- Carpal Tunnel Syndrome, Amyloid Neuropathies, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of ATTR in CTS
Biopsy proven ATTR
Measured: 2 years
Cardiac involvement in patients with biopsy proven ATTR
Scintigraphic and echocardiographic cardiac involvement possibly cMRI
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Sep 2024
- Primary completion28 Feb 2034 (estimated)
- Study completion28 Feb 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATTR Amyloidosis Wild TypeStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Torstein Hole, MD, PhD, Principal investigator, Helse Møre og Romsdal HF and NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458374
- Sponsor's protocol ID
- 715238
- Status last verified
- Aug 2026
- First submitted
- 7 Jun 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Long Tem Follow up of ATTR Cardiac Amyloidosis in a Selected Population of Patients Operated on Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06458374
- Acronym / sponsor ID
- 715238
- Conditions
- ATTR Amyloidosis Wild Type, ATTR Gene Mutation, Carpal Tunnel Syndrome, Cardiac Amyloidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 28 Feb 2034 (estimated)
- Study completion
- 28 Feb 2039 (estimated)
- First posted
- 13 Jun 2024 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Maximum 200 patients operated at Ålesund Hospital for CTS
Key inclusion criteria (3 listed)
- Male > 50 years
- Female > 60 years
- operated CTS at Ålesund Hospital
Key exclusion criteria (5 listed)
- 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
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
Frequency of ATTR in CTS
Time frame: 2 years
Biopsy proven ATTR
Cardiac involvement in patients with biopsy proven ATTR
Time frame: 10 years
Scintigraphic and echocardiographic cardiac involvement possibly cMRI
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 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Torstein Hole, MD, PhD principal investigator
Helse Møre og Romsdal HF and NTNU
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 ATTR Amyloidosis Wild Type and ATTR Gene Mutation, run by Helse Møre og Romsdal HF at 1 site in Norway.
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 3 inclusion and 5 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 12 Aug 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 Norway. 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 Torstein Hole, Professor, MD, PhD (+4770105000, +4793421002, torstein.hole@helse-mr.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of ATTR in CTS (time frame: 2 years). The study lists 2 primary outcomes in all. 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 12 Aug 2026.