Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM) in Patients With Idiopathic Peripheral Neuropathy

NCT04985734 | Unknown

• 1 other identifier: EDGE1850
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the present study is to determine the occurrence of wild-type and hereditary transthyretin amyloidosis cardiomyopathy among patients with the diagnosis of idiopathic peripheral neuropathy in the setting of a state-of-the-art diagnostic work-up; the investigators believe that the identification of patients with ATTR-CM in this setting can contribute to the early diagnosis of a largely underrecognized condition and, therefore, offer conditions to timely initiation of appropriate therapy with impact on prognosis of patients.

Conditions

Amyloidosis Cardiac; Amyloid Polyneuropathy; Amyloidosis; Heart Failure; Cardiomyopathy Non-Dilated; Cardiomyopathies, Secondary

Keywords

Amyloidosis Cardiac; Amyloid Polyneuropathy; Amyloidosis; Heart Failure; Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Diagnosis yield

  Diagnosis yield of Tc-scintigraphy as a screening tool for ATTR-CM, as measured by the percentage of patients with a confirmed diagnosis of ATTR-CM in relation to the whole population of patients studied

  1 year

Study Arms (1)

Patients under diagnostic work-up

EXPERIMENTAL

Diagnostic Test: Specific diagnostic work-up for ATTR-CM patients

Interventions

Specific diagnostic work-up for ATTR-CM patients DIAGNOSTIC_TEST

Technetium-scintigraphy

Patients under diagnostic work-up

Eligibility Criteria

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

You may qualify if:

• \- Adult patients (\> 18 years old) with diagnosis of idiopathic peripheral neuropathy

You may not qualify if:

• Patients with alternative established diagnosis of heart disease (ischemic heart disease, primary valvular heart disease, cardiomyopathies, pericardial disease)
• Patients with end stage renal disease undergoing dialysis
• Patients with other medical conditions recognized to impair the 1-year prognosis of patients

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Emeline van Craenenbroek

Edegem, Antwerp, 2610, Belgium

Location

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Amyloid Neuropathies; Amyloidosis; Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Proteostasis Deficiencies; Heart Diseases; Cardiovascular Diseases

Study Design

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

Model Details: Cohort of patients

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: August 2, 2021
• Study Start: October 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

BE (1)