The purpose of this study is to confirm that the treatment with acoramidis prevents the deterioration of the ATTR-CM disease progression index and that these indexes are surrogate markers of disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Participants will receive acoramidis tablets orally.
Research Site
Bunkyō City, Japan
NOT_YET_RECRUITINGResearch Site
Bunkyō City, Japan
NOT_YET_RECRUITINGDisease Progression Rate as Measured by N-terminal pro-brain-type Natriuretic Peptide (NT-proBNP) and/or Outpatient Diuretic Intensification (ODI)
Time frame: Baseline through 12 months
Disease Progression Rate as Measured by NT-proBNP and/or High-sensitivity Cardiac Troponin T (hs-CTnT)
Time frame: Baseline through 12 months
Change from Baseline in Serum Transthyretin (TTR)
Time frame: Baseline, 28 days
Number of Participants with a 30% Change from Baseline in NT-proBNP
Time frame: Baseline, 12 months and 18 months
Change from Baseline in hs-CTnT
Time frame: Baseline, 12 months and 18 months
Change from Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Overall Summary Score
Time frame: Baseline, 12 months and 18 months
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, 12 months and 18 months
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Research Site
Kumamoto, Japan
NOT_YET_RECRUITINGResearch Site
Kurume-shi, Japan
RECRUITINGResearch Site
Kyoto, Japan
NOT_YET_RECRUITINGResearch Site
Mitaka-shi, Japan
NOT_YET_RECRUITINGResearch Site
Nagoya, Japan
NOT_YET_RECRUITINGResearch Site
Nankoku-shi, Japan
NOT_YET_RECRUITINGResearch Site
Okayama, Japan
NOT_YET_RECRUITINGResearch Site
Ōtsu, Japan
NOT_YET_RECRUITING...and 6 more locations