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Recruiting NCT06458374

ATTR Cardiac Amyloidosis in a Selected Population

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: ATTR Amyloidosis Wild Type, ATTR Gene Mutation, Carpal Tunnel Syndrome, Cardiac Amyloidosis. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prevalence and Long Tem Follow Up of ATTR Cardiac Amyloidosis in a Selected Population of Patients Operated on Carpal Tunnel Syndrome

Overview

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.

Primary outcome measures

  • Frequency of ATTR in CTS [Time frame: 2 years]
  • Cardiac involvement in patients with biopsy proven ATTR [Time frame: 10 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Norway · 1 center
  • Ålesund Hospital — Ålesund

Identifiers

NCT: NCT06458374 · 715238

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗