Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05950867
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-04-21
Brief Title:
Prevalence of Wild-type TTR Cardiac Amyloidosis in Patients With Polyneuropathy of Unknown Cause
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
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:
2023-11
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 andor 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 andor 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 NCVEMG 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 NCVEMG data and Sudoscan extracted from the medical file of the participants
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None