NCT05950867

Prevalence of Wild-type TTR Cardiac Amyloidosis in Patients With Polyneuropathy of Unknown Cause.

Prevalence of Wild-type TTR Cardiac Amyloidosis in Patients With Polyneuropathy of Unknown Cause: a Prospective Monocentric Study (CAP-TTR)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

To investigate to what extent chronic axonal length-dependent polyneuropathy (CAP) and/or small-fiber neuropathy (SFN) is part of early non-cardiac manifestations of wild-type TTR cardiac amyloidosis (wtTTR-CA). Consequently, explore whether this could ultimately lead to faster diagnosis and clinical outcome of wild-type TTR cardiac amyloidosis (wtTTR-CA).

Detailed description

Patients with chronic axonal length-dependent polyneuropathy (CAP) and/or small-fiber neuropathy (SFN) without well-defined cause will be recruited after a neurological standard routine work-up with NCS (Nerve conduction study) test, EMG, and Sudoscan®, previously performed at the neurology department of UZ-Brussel in normal clinical setting. All participants will be invited to the Neurology and Cardiology department for one visit on one day, for the following assessments: Following exams will be performed: * assessment of symptoms, severity, and duration of the polyneuropathy and the use of NTSS-6 and COMPASS31 score for mapping somatosensory and autonomic symptoms * evaluation of objective polyneuropathy signs, using following scales: mPND, NIS * Kansas City Cardiomyopathy Questionnaire (KCCQ) * Electrocardiogram (ECG) * Echocardiography The following retrospective data from the medical file will be analyzed: * assessment of medical history, medical treatment, and demographic data * assessment of laboratory results (and, if applicable, other exams) extracted from the medical file and previously performed in the context of polyneuropathy workup * assessment of previously performed NCV/EMG data and Sudoscan®, extracted from the medical file of the participants.

Conditions

• Polyneuropathy
• Amyloidosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ECG + echocardiography	Electrocardiogram and echocardiography
OTHER	Answering questionnaires	Answering questionnaires about polyneuropathy symptoms (NTSS -6, COMPASS31, NIS, mPND) and also cardialogical symptoms (KCCQ-12).

Timeline

• Start date: 2023-07-28
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-07-18
• Last updated: 2025-07-22

Locations

1 site across 1 country: Belgium