Flowchart of study visits
| Visit 0 | Visit 1 | Phone contacts | Visit 2 | Visit 3 | Visit 4 | |
|---|---|---|---|---|---|---|
| Screening | Randomi- sation | Clinical control | End of first period | End of second period | ||
| Time (weeks) | −1– −4 | 0 | — | 3±2 | 12±2 | 24±2 |
| General | ||||||
| Assessment of inclusion and exclusion criteria | X | X | ||||
| Demography | X | |||||
| Medical history | X | |||||
| Endpoints | ||||||
| Echocardiography | X | X | X | |||
| Six-minute walk test | X | X | ||||
| Blood pressure | X | X | X | X | X | |
| Minnesota Living with Heart Failure questionnaire | X | X | ||||
| Clinical assessment | ||||||
| Physical assessment | X | X | X | X | X | |
| ECG | X | X | X | |||
| Biosamples | ||||||
| Biobank/biomarkers | X | X | ||||
| U-albumin/creatinine | X | X | ||||
| Safety | ||||||
| Adverse events | X | X | X | X | X | |
| Blood tests | X | X | X | X | ||
| Study medication | ||||||
| Study drug dose titration | X | |||||
| Concomitant medication | X | X | X | X | X | X |