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

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Polyneuropathy; Amyloidosis

Treatments: Diagnostic Test: ECG + echocardiography; Other: Answering questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT05950867

EC-2023-115

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic axonal length-dependent polyneuropathy (CAP) and/or small-fiber neuropathy (SFN) without well-defined etiology.
• Age: >= 60 years
• Male and female gender
• Written informed consent

Exclusion criteria

• Known cause of polyneuropathy
• Other types of peripheral neuropathy than chronic axonal length-dependent polyneuropathy (CAP) and/or small-fiber neuropathy (SFN).
• Patients younger than 60 years

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

1 arm including patients with CAP and/or SFN

Other group

Description:

1 arm including patients with chronic axonal length-dependent polyneuropathy and/or small-fiber neuropathy. All participants will be screened with ECG and echocardiography. All participants will be asked to complete questionnaires about there polyneuropathy and cardiological symptoms.

Treatment:

Other: Answering questionnaires

Diagnostic Test: ECG + echocardiography