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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04985734
Other study ID # EDGE1850
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date July 1, 2025

Study information

Verified date July 2021
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Background. Different studies have described the value of amyloidosis screening in different clinical settings. The investigators hypothesize that in a relevant yet undetermined proportion of patients with idiopathic peripheral neuropathy a concomitant diagnosis of transthyretin amyloidosis cardiomyopathy can be made with a modern diagnostic work-up based on Technetium-scintigraphy as the primary screening tool. Further the investigators believe that the identification of these patients can lead to early initiation of therapy and modification of the prognosis of the disease. Objective. To study the occurrence of transthyretin amyloidosis cardiomyopathy in patients with a diagnosis of idiopathic peripheral neuropathy using Tc-scinfigraphy as the primary screening tool. Methods. This will be a prospective longitudinal cohort of adult patients with the diagnosis of idiopathic peripheral neuropathy. All patients will be submitted to a cardiologic evaluation that will include clinical evaluation, laboratory tests, electrocardiogram and echocardiography. For the diagnosis of amyloidosis all patients will be submitted to 99mTc-Methyl-Diphosphonate scintigraphy. Those with a positive result (grade 2 to 3 cardiac uptake) will be considered as having diagnosis of transthyretin amyloidosis cardiomyopathy and will be further submitted to genetic testing for transthyretin mutation; patients with abnormal scintigraphic results that do not meet current semi-quantitative diagnostic criteria will be submitted to additional investigation, that will include magnetic resonance heart imaging and fat biopsy. All patients will receive standard care for heart failure and transthyretin amyloidosis cardiomyopathy and will be follow-up every 6 months with clinical parameters, quality life questionnaire, ergospirometer and echocardiogram Perspectives. The investigators believe that the identification of patients with transthyretin amyloidosis cardiomyopathy in this setting can contribute to the early diagnosis of a largely underrecognized condition and, therefore, offer conditions to timely initiate appropriate therapy with impact on prognosis of patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date July 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria - Adult patients (> 18 years old) with diagnosis of idiopathic peripheral neuropathy Exclusion criteria - 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

Study Design


Intervention

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

Locations

Country Name City State
Belgium Emeline van Craenenbroek Edegem Antwerp

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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