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RecruitingNCT06458374Updated Aug 12, 2026

ATTR Cardiac Amyloidosis in a Selected Population

An observational study in ATTR Amyloidosis Wild Type, ATTR Gene Mutation and Carpal Tunnel Syndrome, sponsored by Helse Møre og Romsdal HF. Recruiting at 1 site in Norway. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Helse Møre og Romsdal HF · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
180
Ages
50 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • ATTR Amyloidosis Wild Type
  • ATTR Gene Mutation
  • Carpal Tunnel Syndrome
  • Cardiac Amyloidosis
03

In context

Carpal Tunnel Syndrome

587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.

This study's planned enrollment of 180 is above the median of 94 across 130 observational studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Helse Møre og Romsdal HF is the lead sponsor of 24 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Maximum 200 patients operated at Ålesund Hospital for CTS

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male > 50 years
  • Female > 60 years
  • operated CTS at Ålesund Hospital

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Frequency of ATTR in CTS

    Biopsy proven ATTR

    Time frame: 2 years

  2. Cardiac involvement in patients with biopsy proven ATTR

    Scintigraphic and echocardiographic cardiac involvement possibly cMRI

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06458374
Lead sponsor
Helse Møre og Romsdal HF
Responsible party
Sponsor
First posted
Jun 13, 2024
Start date
Sep 1, 2024
Primary completion
Feb 28, 2034 (estimated)
Completion
Feb 28, 2039 (estimated)
Last update
Aug 12, 2026

Study contacts

Torstein Hole, Professor, MD, PhD
Contact
torstein.hole@helse-mr.no
+4770105000, +4793421002
Jørn A Lillebø, consultant cardiology, MD
Contact
jorn.asle.lillebo@helse-mr.no
+4770105000
Torstein Hole, MD, PhD
principal investigator · Helse Møre og Romsdal HF and NTNU

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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