Table 2. Control group (delayed-start canagliflozin group).
Visit | Observation period | ||||||
Before starting | Week 0 | Week 12(month 3) | Week 24(month 6) | Week 36(month 9) | Week 48(month 12) | Week 76(month 18) | |
Schedule window | – | – | ±6 week | ±9 week | ±12 week | ±12 week | ±12 week |
Informed consent | X | ||||||
Enrolment | X | ||||||
Allocation | X | ||||||
Patient characteristics | X | ||||||
Physical examination | X | X | X | X | X | X | X |
Blood test | X | X | X | X | X | X | |
Plasma BNP | X | X | X | X | X | X | |
Image tests* | X | X | X | X | |||
Kt/Vurea, PET† | X | 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 from 12 weeks prior to the start of observation to week 0.
Kt/Vurea, PET; week 0 should be performed 24 weeks prior to the start of administration to 0 week. Week 48 is not required.
BNPbrain natriuretic peptidePETperitoneal equilibration test