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Recruiting

NCT Number: NCT06458374

ATTR Cardiac Amyloidosis in a Selected Population

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.

Recruiting

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Key information

Conditions

ATTR Amyloidosis Wild Type ATTR Gene Mutation Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Amyloidosis, Familial Cardiac Amyloidosis Carpal Tunnel Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cumulative Trauma Disorders Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Median Neuropathy Metabolic Diseases Metabolism, Inborn Errors Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Proteostasis Deficiencies Sprains and Strains Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency of ATTR in CTS

    Time frame: 2 years

    Biopsy proven ATTR

  2. Cardiac involvement in patients with biopsy proven ATTR

    Time frame: 10 years

    Scintigraphic and echocardiographic cardiac involvement possibly cMRI

Study contacts

Contact information is provided by the study sponsor or research team.

Jørn A Lillebø, consultant cardiology, MD

CONTACT

[email protected]

+4770105000

Torstein Hole, Professor, MD, PhD

CONTACT

[email protected]

+4770105000, +4793421002

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2034
Study completion
2039
First posted
Jun 13, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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