Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-31 @ 4:03 AM
Study NCT ID:
NCT05950867
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2023-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Wild-type TTR Cardiac Amyloidosis in Patients With Polyneuropathy of Unknown Cause.
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Study Overview
Official Title:
Prevalence of Wild-type TTR Cardiac Amyloidosis in Patients With Polyneuropathy of Unknown Cause: a Prospective Monocentric Study (CAP-TTR)
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: