Transthyretin Amyloidosis Clinical Trial
— AMYLOIDOZAOfficial title:
The Comparisons of Regional Scintigraphic DPD Uptake Between Patients With Hereditary and Wild Type Cardiac Transthyretin Amyloidosis
NCT number | NCT05814380 |
Other study ID # | ID#57165999 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 4, 2020 |
Est. completion date | March 1, 2024 |
Cardiac transthyretin (ATTR) amyloidosis is an infiltrative cardiomyopathy with an inexorably progressive clinical course and poor prognosis. The disease is caused by misfolding of the liver-derived precursor protein transthyretin as a result of an acquired wild-type variant (ATTRwt) or as a hereditary mutant variant (ATTRm). Application of single-photon emission computed tomography (SPECT) provides greater anatomic resolution, enabling the assessment of amyloid burden within individual left ventricle segments.This study aims to describe the pattern of regional myocardial distribution of 3,3-diphosphono-1,2-propanedicarboxylic acid (DPD) SPECT uptake among patients with ATTRwt and ATTRm. It will investigate the clinical, biochemical and echocardiographic, including left ventricle longitudinal strain profile in ATTRwt and ATTRm. Moreover, we will evaluate the presence and extent of DPD cardiac uptake among asymptomatic ATTRm variants carriers.This is a prospective multi-center observational study. The study, after obtaining prior written informed consent, will include consecutive patients who have Grade 1-3 cardiac DPD retention in scintigraphy. In addition, first-degree relatives of patients with ATTRm are going to be enrolled. Patients are going to undergo TTR gene sequencing to assess the presence of pathogenic variants associated with ATTRm. Both planar scintigraphy, SPECT and speckle-tracking echocardiography will be reviewed and interpreted using visual and quantitative approaches.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - over 18 years of age, - providing written informed consent, - grade 1-3 cardiac retention of 99mTc-DPD in scintigraphic study or a first-degree relative of a patient with ATTR Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Cardiac and Vascular Diseases, John Paul II Hospital | Krakow | Lesser Poland |
Lead Sponsor | Collaborator |
---|---|
Katarzyna Holcman |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | left ventricle longitudinal strain | To investigate echocardiographic left ventricle longitudinal strain profile in hereditary and wild-type ATTR cardiac amyloidosis. | day 1 | |
Primary | regional left ventricle 99mTc-DPD uptake | To compare the regional left ventricle 99mTc-DPD uptake among patients with hereditary and wild-type cardiac transthyretin amyloidosis. | day 1 | |
Secondary | right ventricular 99mTc-DPD accumulation | To assess prevalence of right ventricular 99mTc-DPD accumulation among patients with hereditary and wild-type cardiac transthyretin amyloidosis. | day 1 | |
Secondary | 99mTc-DPD cardiac uptake among asymptomatic hereditary transthyretin amyloidosis variants carriers | To evaluate the presence and extent of 99mTc-DPD cardiac uptake among asymptomatic hereditary transthyretin amyloidosis variants carriers. | day 1 |
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