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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06458374

Enrollment

180

Registered

2024-06-13

Start date

2024-09-01

Completion date

2039-02-28

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ATTR Amyloidosis Wild Type, ATTR Gene Mutation, Cardiac Amyloidosis, Carpal Tunnel Syndrome

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Frequency of ATTR in CTS	2 years	Biopsy proven ATTR
Cardiac involvement in patients with biopsy proven ATTR	10 years	Scintigraphic and echocardiographic cardiac involvement possibly cMRI

Countries

Norway

Contacts

CONTACTTorstein Hole, Professor, MD, PhD

torstein.hole@helse-mr.no+4770105000, +4793421002

CONTACTJørn A Lillebø, consultant cardiology, MD

jorn.asle.lillebo@helse-mr.no+4770105000

PRINCIPAL_INVESTIGATORTorstein Hole, MD, PhD

Helse Møre og Romsdal HF and NTNU

Outcome results