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

NCT05950867 | Recruiting

• 1 other identifier: EC-2023-115
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Polyneuropathy; Amyloidosis

Outcome Measures

Primary Outcomes (3)

• Primary Outcome: Evaluation of prevalence of wild-type cardiac amyloidosis in our CAP and/or SFN population without well known cause.

  Prevalence of cardiac amyloidosis by doing a cardiac screening for wild-type cardiac amyloidosis with performing an echocardiography. Echocardiography criteria: LV wall (\>12mm), left ventricular ejection fraction (%), Apical sparing pattern (y/n), diastolic dysfunction (y/n), left atrial volume (ml/m2). Left atrial volume in ml and LA volume in ml/m2, whereby m2 is the body surface area based on weight and height (Mosteller formula).

  36 months

• Primary Outcome: Evaluation of prevalence of wild-type cardiac amyloidosis in our CAP and/or SFN population without well known cause

  Prevalence of cardiac amyloidosis by doing a cardiac screening for wild-type cardiac amyloidosis with performing an ECG. ECG criteria: atrial fibrillation (y/n), QRS-duration, low voltage (y/n)

  36 months

• Primary Outcome: Evaluation of prevalence of wild-type cardiac amyloidosis in our CAP and/or SFN population without well known cause

  Prevalence of cardiac amyloidosis by doing a cardiac screening for wild-type cardiac amyloidosis with performing a questionnaire (Kansas City Cardiomyopathy Questionnaire). KCCQ-12 has 4 domains (Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score) and one Summary Score. Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest. This descriptive score will be used as a functional parameter without a cut-off.

  36 months

Secondary Outcomes (7)

• Secondary outcome: severity and evolution

  36 months

• Secondary outcome: severity and evolution

  36 months

• Secondary outcome: severity and evolution

  36 months

• Secondary outcome: severity and evolution

  36 months

• Secondary outcome: red flags that could increase the awareness of neurologists for wild-type TTR-cardiac amyloidosis

  36 months

Study Arms (1)

1 arm including patients with CAP and/or SFN

OTHER

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.

Diagnostic Test: ECG + echocardiography; Other: Answering questionnaires

Interventions

ECG + echocardiography DIAGNOSTIC_TEST

Electrocardiogram and echocardiography

1 arm including patients with CAP and/or SFN

Answering questionnaires OTHER

Answering questionnaires about polyneuropathy symptoms (NTSS -6, COMPASS31, NIS, mPND) and also cardialogical symptoms (KCCQ-12).

1 arm including patients with CAP and/or SFN

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Belgium Capital City, 1090, Belgium

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Polyneuropathies; Amyloidosis

Interventions

Electrocardiography; Echocardiography

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Study Officials

• Veronique Bissay, MD, Phd

  UZ Brussel - VUB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique Bissay, MD,Phd

CONTACT

+32 2 477 68 01; veronique.bissay@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: July 18, 2023
• Study Start: July 28, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)