Table 1. Observation, test and evaluation schedule canagliflozin treatment group.
Visit | Observation period | ||||
Before starting | Week 0 | Week 12 (month 3) | Week 24 (month 6) | Week 52 (month 12) | |
Schedule window | – | – | ±6 week | ±9 week | ±12 week |
Informed consent | X | ||||
Enrolment | X | ||||
Allocation | X | ||||
Patient characteristics | X | ||||
Physical examination | X | X | X | X | X |
Blood test | X | X | X | X | |
Plasma BNP | X | X | X | X | |
Image tests* | X | X | X | ||
Kt/Vurea, PET† | X | X | X | ||
Use of concomitant drugs | |||||
Adverse events |
Image tests; CT scan, cardiac echo, cervical echo, Holter ECG, chest X-ray and bone mineral density measurement at week 0 should be performed 12 weeks prior to the start of administration to week 0.
Kt/Vurea, PET; week 0 should be performed 24 weeks prior to the start of administration to 0 week. Week 24 is not required.
BNPbrain natriuretic peptidePETperitoneal equilibration test