Transthyretin amyloidosis ATTR-CM
Conditions
Interventions
To prescribe tafamidis for 1 year in patients with ATTR-CM and to evaluate the pathophysiological impacts of tafamidis on cardiac transthyretin amyloidosis
Sponsors
Fujimoto Naoki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)heart failue patients with transthyretin amyloidosis (2)patients with transthyretin amyloidosis confirmed by myocardial biopsy (3)patients with LV thickness equal and/or greater than 12 mm (4)patients wth age equal and/or greater than 20 (5)men and women (6)patients with NYHA 1 to 3 (7) patients with LV hypertrophy (and diastolic dysfunction) caused by amyloid deposition
Exclusion criteria
Exclusion criteria: (1) patients with severe valcular disease (2) patients with NYHA4 heart failure (3) patients with acute coronary syndrome (4) patients with cardiogenic shock (5) patients with severe liver failure (6) patients with stage 5 kidney disease (7) patients with infectious disease (8) patients with a a life expectancy of less than 1 year (9) pregnant patients (10) patients who are unable to walk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change on the area of amyloid deposition in the myocardial biopsy specimen from right ventricular septum before and 1 year after treatment with tafamidis | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) the way of amyloid deposition, the extent of interstitial fibrosis and inflammatory cell infiltration, and the degree of myocardial cell injury assessed by myocardial biopsy from ventricular septum (2) cardiac function by echocardiography, cardiac MRI, and conductance catheter (3) six minutes walk test, activity monitoring, peak oxygen uptake and quality of life (4) heart failure severity (5) blood tests (BNP, troponin T, etc) | — |
Contacts
Public ContactNaoki Fujimoto
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Mie
Outcome results
None listed