ClinicalTrials.gov record NCT05950867

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age60 years old and older

SexAll

LocationBelgium

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This single-group screening study invites people with chronic axonal length-dependent polyneuropathy (CAP) and/or small-fiber neuropathy (SFN) without a well-defined cause to undergo cardiac screening for wild-type TTR cardiac amyloidosis. Participants have one combined neurology and cardiology visit with questionnaires, an ECG, and an echocardiogram. Investigators will also review prior nerve tests and medical records.

What it is studying. The study measures how common wild-type transthyretin (TTR) cardiac amyloidosis is in patients who have CAP and/or SFN of unknown cause. It also looks for patterns in heart tests and symptom questionnaires that might link neuropathy with early, non-cardiac signs of this type of cardiac amyloidosis.

What the researchers hope to learn. To estimate the prevalence of wild-type TTR cardiac amyloidosis in this neuropathy population; to describe cardiac (ECG, echo) findings and questionnaire scores; and to identify clinical 'red flags' (for example, carpal tunnel syndrome, spinal stenosis, trigger finger) that could raise neurologists' awareness of possible cardiac amyloidosis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test: ECG + echocardiography
Other: Answering questionnaires

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Attend one combined neurology and cardiology visit on a single day to complete questionnaires about neuropathy and heart symptoms (NTSS‑6, COMPASS‑31, NIS, mPND, KCCQ‑12), have an electrocardiogram (ECG) and an echocardiogram, and allow study staff to review your medical record and previous nerve test results (NCS/EMG and Sudoscan). The main study procedures are non‑invasive tests and questionnaires. You will be asked to provide written informed consent before any study activities.

How the study is structured. Single-group, non-masked interventional screening study. Each participant attends one combined visit for ECG, echocardiography, and symptom questionnaires; the team also analyzes existing nerve-conduction/EMG results and other prior medical data from participants' records.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Polyneuropathy; Amyloidosis. Does it apply to my diagnosis?
The listed sites are in Belgium. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jul 28, 2023
Primary completion: Jun 1, 2026 (estimated)
Study completion: Jun 1, 2026 (estimated)
Target enrollment: 150 participants (estimated)
Last updated on registry: Jul 22, 2025
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Universitair Ziekenhuis Brussel
Principal investigator: Veronique Bissay, Principal Investigator
Universitair Ziekenhuis Brussel

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Véronique Bissay, MD,Phd 📞 +32 2 477 68 01 ✉ veronique.bissay@uzbrussel.be

Participating sites (1)

UZ BrusselRecruiting
Jette, Belgium Capital City, 1090 · Belgium
- Veronique Bissay, MD, PhD · +32 2 477 68 01 · veronique.bissay@uzbrussel.be
- Steven Droogmans, MD, PhD · +32 2 477 60 09 · steven.droogmans@uzbrussel.be
- Véronique Bissay, MD, Phd
- Steven Droogmans, MD, Phd

Terms used on this page · explanations by MedicalUpdates.ai

Written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Electrocardiogram: A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Echocardiography: An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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