ATTR Cardiac Amyloidosis in a Selected Population

Recruiting

• Conditions: Carpal Tunnel Syndrome; ATTR Gene Mutation; Cardiac Amyloidosis; ATTR Amyloidosis Wild Type

• Registration Number: NCT06458374
• Lead Sponsor: Helse Møre og Romsdal HF

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-13
• Study Start: 2024-09-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2034-02-28
• Study Completion: 2039-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ålesund Hospital; 🇳🇴 Ålesund, Møre og Romsdal, Norway