ATTR Cardiac Amyloidosis in a Selected Population

NCT ID: NCT06458374

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2039-02-28

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Møre og Romsdal HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torstein Hole, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Møre og Romsdal HF and NTNU

Locations

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Ålesund Hospital

Ålesund, Møre og Romsdal, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Torstein Hole, Professor, MD, PhD

Role: CONTACT

+4770105000, +4793421002

Jørn A Lillebø, consultant cardiology, MD

Role: CONTACT

+4770105000

Facility Contacts

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Torstein Hole, PhD

Role: primary

+4770105000

Jørn A Lillebø, MD

Role: backup

+4770105000

Other Identifiers

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715238

Identifier Type: -

Identifier Source: org_study_id

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