Table 1.
RECEDE-CHF trial protocol
| Visit | Visit 1* (screening) | Visit 2* (baseline/randomisation) | Visit 3 | Visit 4 (televisit) |
Visit 5 | Two- week washout period | Visit 6 | Visit 7 | Visit 8 (televisit) |
Visit 9 (final visit§) |
| Week | Up to 4 weeks pre visit 2 | Day 0 | Day 3 (±2 days) |
Week 3 (±3 days) |
Week 6 (±3 days) |
Week 9 (±3 days) |
Week 9+3 days (±2 days) | Week 12 (±3 days) | Week 15 (±3 days) |
|
| Informed consent | X | |||||||||
| Inclusion/exclusion criteria | X | X | X | X | ||||||
| Medical history | X | |||||||||
| Demographics | X | X | X | X | ||||||
| Vital signs | X | X | X | X | X | X | X | |||
| Safety bloods | X | X | X | X | X | X | X | |||
| Research bloods | X | X | X | X | X | X | ||||
| Genetic blood sample† | X | |||||||||
| uPCR/uACR | X | X | X | X | X | X | ||||
| Urine pregnancy test‡ | X | X | X | X | X | X | X | |||
| 24 urinary collection | X | X | X | X | ||||||
| Renal physiology pest | X | X | X | X | ||||||
| Drug dispensing | X | X | ||||||||
| AE assessment | X | X | X | X | X | X | X | X | ||
| Record/review medications | X | X | X | X | X | X | X | X | X | |
| Drug compliance check | X | X | X | X | X | X |
*Visits one and two combined into one visit where able.
†Only to be taken if participant consent given.
‡Testing on women of childbearing potential or who do not abstain from sex or use effective contraception.
§If the participant wishes to withdraw prematurely or at the principal investigator’s discretion, all study procedures will be conducted as though the final visit, if participant agrees.
AE, adverse events; RECEDE-CHF, Renal and Cardiovascular Effects of SGLT2 inhibition in combination with loop Diuretics in diabetic patients with Chronic Heart Failure; uACR, urine albumin/creatinine ratio; uPCR, urine protein/creatinine ratio.