Table 2.
Study visits and procedures.
| Visit | Washout | 1 | 2 | 3 | 4 | 5 | ||
|---|---|---|---|---|---|---|---|---|
| Week | −2 | 0 | 4a | 8a | 12a | 26a | 38a | 52 |
| Informed consent taking | ×b | ×b | Phone call follow-up | Phone call follow-up | ||||
| Demographics and anthropometrics collection | ×b | ×b | ||||||
| Collection of past medical history, including medications | ×b | ×b | ||||||
| Urine pregnancy test | × | × | × | × | × | × | ||
| Randomization | × | |||||||
| Health-related quality of life assessment | × | × | × | |||||
| Study medication dispense | × | × | × | × | ||||
| Medication adherence check | × | × | × | × | × | |||
| Blood collection for renal function and potassium level | × | × | × | × | × | |||
| Blood collection for hematocrit | × | × | ||||||
| Blood collection for storage | × | × | ||||||
| Office blood pressure measurement | × | × | × | × | × | |||
| 24-h ambulatory blood pressure monitoring | × | × | × | × | × | |||
| Cardiovascular magnetic resonance | × | × | ||||||
| Adverse events evaluation | × | × | × | × | × |
Additional clinic visits are arranged if necessary.
These procedures are only done once, either at the washout visit or visit 1.