Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
ID05950867

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

Led by Universitair Ziekenhuis Brussel · Updated on 2025-07-22

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether chronic axonal length-dependent polyneuropathy (CAP) and/or small-fiber neuropathy (SFN) might be early signs of wild-type TTR cardiac amyloidosis (wtTTR-CA), a heart condition. The study aims to explore if recognizing these neuropathies can lead to faster diagnosis and better clinical outcomes for wtTTR-CA. This prospective monocentric study focuses on patients with polyneuropathy of unknown cause. Participants with CAP and/or SFN, who have already undergone nerve conduction studies (NCS), electromyography (EMG), and Sudoscan® testing, will be invited for a single combined neurology and cardiology visit. During this visit, they will undergo assessments including symptom evaluation using NTSS-6 and COMPASS31 questionnaires, physical examination scales (mPND, NIS), a Kansas City Cardiomyopathy Questionnaire (KCCQ), electrocardiogram (ECG), and echocardiography. Retrospective data from their medical records, including previous tests and lab results, will also be reviewed. During the study visit, participants will complete questionnaires on neuropathy and cardiac symptoms and receive heart and nerve function tests. Researchers will analyze the prevalence of wild-type cardiac amyloidosis in this group over 36 months. They will also monitor symptom severity, progression, and identify warning signs that could help neurologists recognize cardiac amyloidosis earlier. The total participation involves one study visit and retrospective data analysis without long-term follow-up visits.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with chronic axonal length-dependent polyneuropathy (CAP) and/or small-fiber neuropathy (SFN) without well-defined cause
  • Age 60 years or older
  • Male and female gender
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Known cause of polyneuropathy
  • Peripheral neuropathy types other than CAP or SFN
  • Patients younger than 60 years

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Single day visit

Participants undergo one visit during which questionnaires about polyneuropathy and cardiological symptoms are completed, and diagnostic tests including electrocardiogram and echocardiography are performed to assess cardiac amyloidosis.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

UZ Brussel

Jette, Belgium Capital City, Belgium, 1090

Actively Recruiting

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Research Team

V

Véronique Bissay, MD,Phd

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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Published Research Related To This Trial

Clinical and apparative investigation of large and small nerve fiber impairment in mixed cohort of ATTR-amyloidosis: impact on patient management and new insights in wild-type.

Aikaterini Papagianni, Sandra Ihne, Daniel Zeller...

https://pubmed.ncbi.nlm.nih.gov/34632904

Characteristics of patients with autonomic dysfunction in the Transthyretin Amyloidosis Outcomes Survey (THAOS).

Fabio A Barroso, Teresa Coelho, Angela Dispenzieri...

https://pubmed.ncbi.nlm.nih.gov/35451899

Prevalence and prognostic value of autonomic neuropathy assessed by Sudoscan® in transthyretin wild-type cardiac amyloidosis.

Mounira Kharoubi, Fréderic Roche, Mélanie Bézard...

https://pubmed.ncbi.nlm.nih.gov/33354901