An interventional study of Specific diagnostic work-up for ATTR-CM patients in Amyloidosis Cardiac, Amyloid Polyneuropathy and Amyloidosis, sponsored by University Hospital, Antwerp. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-02.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Diagnostic
Among 10 studies in Amyloid Neuropathies, Familial with a site in Belgium — 4 open to participants now, 6 under way, 2 of them phase 3. Amyloid Neuropathies, Familial · Belgium.
Among the 10 studies in Amyloid Neuropathies, Familial with a site in Belgium, this one is one of 3 that started in 2021, is the only one with no phase, and was the 6th registered.
188 studies on the registry are indexed under Amyloid Neuropathies, Familial; 94 are open to participants now.
Browse Amyloid Neuropathies, Familial studies →4 of the 10 studies in Amyloid Neuropathies, Familial with a site in Belgium are open now. Recruiting first, the newest first:
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
Eidos Therapeutics, a BridgeBio company · Sites in Belgium, United States, Argentina and 21 more countries
Leiden University Medical Center · Sites in Belgium, Italy, Japan and 2 more countries
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 69 Amyloid Neuropathies, Familial studies recruiting now, 53 (77%) set no upper age limit and 1 (1%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 3 started in 2021.
This study's planned enrollment of 200 is above the median of 54 across 90 interventional studies indexed under Amyloid Neuropathies, Familial.
Median enrollment 441 across the 7 interventional studies, 300 across the 3 observational. Of the 4 that completed or were terminated, 4 (100%) have results posted.
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6 of 10 have an industry lead sponsor. The 7 most frequent:
University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.
University Hospital, Antwerp has 1 study filed under Amyloid Neuropathies, Familial — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Amyloid Neuropathies, Familial with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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Exclusion criteria
Diagnostic Test: Specific diagnostic work-up for ATTR-CM patients
Technetium-scintigraphy
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
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2021; primary completion for Jan 2025, 39 months later.
Of 30 interventional studies with no phase under Amyloid Neuropathies, Familial, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 67. This study's planned 39 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Amyloid Neuropathies, Familial →
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