Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery

Last updated: August 12, 2025
Sponsor: Steen Hvitfeldt Poulsen
Overall Status: Completed

Phase

N/A

Condition

Amyloidosis

Treatment

Tenosynovial biopsy

Clinical Study ID

NCT04276220
1-10-72-178-19
  • Ages > 65
  • All Genders

Study Summary

Patients above the age of 60 will be recruited at their carpal tunnel release surgery. Biopsies will be taken from the wrist and examined for the presence of amyloid protein. A amyloid-positive biopsy will refer the patients for cardiac examination including blod- and urine samples examined for transthyretin.

If the result of the cardiac examination is suspected cardiac amyloidosis, the patient will be referred for a diagnostic TC99-DPD scintigraphy. If the scintigraphy is positive, the patient will be referred for right heart catherization (RHC) and an exercise test.

Myocardial biopsies will be taken at the RHC and examined with electron microscopy and high resolution respirometry.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males above 65 years of age, females above 75 years of age.

  • Scheduled idiopathic carpal tunnel release surgery.

  • Informed written consent.

Exclusion

Exclusion Criteria:

  • Operation by other indication, e.g.

  • Fracture

  • Ganglion

  • Known amyloidosis

Study Design

Total Participants: 109
Treatment Group(s): 1
Primary Treatment: Tenosynovial biopsy
Phase:
Study Start date:
April 01, 2020
Estimated Completion Date:
May 21, 2025

Connect with a study center

  • Aarhus University Hospital

    Aarhus, Jylland 8200
    Denmark

    Site Not Available

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