Neuropathy in Patients Monitored for Wild-type TTR Cardiac Amyloidosis (Non-mutated)

NCT04828928 | Completed

• 1 other identifier: CHUBX 2020/27
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

Brief Summary

Transthyretin (TTR) amyloidosis is a rare disabling disorder that can be hereditary or sporadic. Depending on the form, various tissues are affected. While in hereditary cases, neuropathy is predominant, cardiac impairment is the main manifestation in the sporadic form. The main objective of this project is to evaluate the proportion of patients with neuropathy in a population of patients with a non-mutated TTR amyloid cardiopathy condition.

Conditions

Wild-type Amyloid Cardiopathy

Keywords

wild-type amyloid cardiopathy; neuropathy; descriptive study

Outcome Measures

Primary Outcomes (1)

• Presence of a clinical and/or electrophysiological neuropathy

  The diagnosis of peripheral neuropathy should meet P.J. Dyck's definition of peripheral neuropathy (New England Journal of Medicine, 1982), based on: * the clinical judgment resulting from the standardized clinical examination (carried out by an expert neurologist) and according to the HAS recommendations on the diagnosis of peripheral neuropathies; * electrophysiological abnormalities, interpreted in the clinical context, after an examination carried out by an expert neurophysiologist.

  within 6 months of inclusion (at the time of the electromyogram)

Secondary Outcomes (11)

• Clinical data of patients with polyneuropathy with no identified etiology: Epidemiological characteristics

  within 6 months of inclusion (at the time of the electromyogram)

• Clinical data of patients with polyneuropathy with no identified etiology: history characteristics

  within 6 months of inclusion (at the time of the electromyogram)

• Clinical data of patients with polyneuropathy with no identified etiology: Heart attack

  within 6 months of inclusion (at the time of the electromyogram)

• Clinical data of patients with polyneuropathy with no identified etiology: Clinical scores - KARNOFSKI index

  within 6 months of inclusion (at the time of the electromyogram)

• Clinical data of patients with polyneuropathy with no identified etiology: Clinical scores - NIS-LL-

  within 6 months of inclusion (at the time of the electromyogram)

Study Arms (1)

proportion of patients with neuropathy

EXPERIMENTAL

to prospectively study patients with a wild-type amyloid cardiopathy condition to identify and describe the associated neuropathy

Procedure: electromyogram

Interventions

electromyogram PROCEDURE

Patients meeting the criteria will be seen in consultation with standardized interview and clinical examination. An electromyogram will be then carried out to check for the presence of neuropathy. Finally, for patients diagnosed with neuropathy, a biological check-up to look for another cause of neuropathy will be performed. In patients who already had an EMG as part of their medical follow-up, the examination will not be repeated if it strictly meets the conditions of the minimum protocol and if it was done within the year prior to inclusion. In patients who already had an identical biological assessment in the year prior to inclusion, the sample will not be taken.

proportion of patients with neuropathy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both gender, over 18 years old, with transthyretin amyloid cardiopathy according to one of the two American Heart Association definitions of 2016
• No mutation in the TTR gene
• Patients giving their free and informed consent to participate after information about the research
• Patients affiliated to or benefiting from a social security scheme

You may not qualify if:

• Patients with chronic neuropathy related to a known aetiology
• Patients under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (3)

CHU de Bordeaux

Bordeaux, 33076, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

Study Officials

• Guilhem SOLE, MD

  Université Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 2, 2021
• Study Start: March 23, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)