Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
CompletedResults postedLast updated 12 February 2024
What this trial tests
trial testing Diagnosis of TTR amyloidosis cardiomyopathy in Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM) in 812 participants. Completed in 8 June 2022.
Adults 50 to 99, any sex, with Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1Primary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of participants with cardiac fixation on a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD or 99mTc-PYP or 999mTc-HMDP among participants with LVH from an undiagnosed etiology were reported in this outcome measure. Scintigraphy was defined at each bone site according to the standard grading: Grade 0 = absent cardiac uptake, Grade 1=mild uptake less than bone, Grade 2=moderate uptake equal to bone and Grade 3=high uptake greater than bone.
Group
Value
95% CI
All Participants
32.0
28.8 – 35.4
Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1Secondary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues.
Group
Value
95% CI
All Participants
17.9
15.3 – 20.8
Percentage of Participants With ATTR or With Suspicion of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Light Chain Amyloidosis (AL): FAS 1Secondary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues.
Group
Value
95% CI
All Participants
25.2
22.3 – 28.4
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 2 (FAS 2)Secondary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
Group
Value
95% CI
All Participants
6.5
3.8 – 10.8
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 3 (FAS 3)Secondary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
Group
Value
95% CI
All Participants
6.9
4.1 – 11.5
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.1Secondary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
Group
Value
95% CI
All Participants
8.7
4.9 – 14.8
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.2Secondary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.
Group
Value
95% CI
All Participants
3.7
1.0 – 12.5
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 2Secondary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
Group
Value
95% CI
All Participants
93.5
89.2 – 96.2
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3Secondary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
Group
Value
95% CI
All Participants
93.1
88.5 – 95.9
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.1Secondary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
Group
Value
95% CI
All Participants
91.3
85.2 – 95.1
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.2Secondary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.
Group
Value
95% CI
All Participants
96.3
87.5 – 99.0
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 2Secondary· During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.
Group
Value
95% CI
All Participants
13
Sponsor's own description
The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) \>15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 12 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03842163.