NIPH Clinical Trials Search

SILENCE-TTR

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Transthyretin cardiac amyloidosis
Date of first enrollment	13/01/2026
Target sample size	360
Countries of recruitment
Study type	Interventional
Intervention(s)	Patients with ATTR-CM will be randomly assigned to receive either a TTR silencer (vutrisiran) or a TTR stabilizer (tafamidis or acoramidis).

Outcome(s)

Primary Outcome

The percentage change from baseline in standardized uptake value SUV on myocardial scintigraphy 99mTc HMDP or 99mTc PYP SPECT CT at week 52 after treatment initiation

Secondary Outcome

1.Incidence and time to first onset of cardiac amyloidosis related adverse events at 104w after treatment initiation 2.Percent and absolute changes from baseline in the following parameters at 52w and 104w after treatment initiation -Myocardial scintigraphy 99mTc HMDP or 99mTc PYP SPECT CT standardized uptake value SUV at 104w -Cardiac MRI parameters late gadolinium enhancement LGE extracellular volume ECV and native T1 and T2 -Echocardiographic parameters left ventricular mass index LVMi left atrial volume index LAVI apical sparing ratio left ventricular ejection fraction LVEF and left ventricular volumes -Biomarkers NT proBNP or BNP troponin T or I transthyretin TTR and thyroid function free T4 free T3 and TSH -6 minute walk distance 6MWD -Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ OS -Short Physical Performance Battery SPPB, Handgrip strength , Clinical Frailty Scale

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients aged 18 years or older at the time of obtaining consent 2) Patients diagnosed with ATTR-CM who meet the criteria for disease-modifying therapy in Japan 3) New York Heart Association (NYHA) functional class 1-3 4) CohortA) Newly diagnosed with ATTR-CM and not receiving treatment with tafamidis, acoramidis, or butyric acid CohortB) Those already diagnosed with ATTR-CM and receiving treatment with Tafamidis or Acoramidis 5) Patients for whom written consent has been obtained from the patient themselves or their authorized representative
Exclude criteria	1) Diagnosis of light-chain (AL) amyloidosis 2) Diagnosis of hereditary ATTR-CM (variant TTR genotype) 3) Maintaining dialysis patients 4) Patients with hypersensitivity to either Tafamidis, Acolamis, or Butiriciran 5) Patients who are already participating in or plan to participate in other clinical trials during the study period 6) Patients deemed unsuitable for participation in this study by the principal investigator or co-investigator for other reasons