Table 1.
Assessment | Screening and randomisation visits | Follow-up visits | Unscheduled | |||||||||||
Screening period (Baseline) | Randomisation | Follow-up 1 | Follow-up 2 | Follow-up 3 | Follow-up 4 | Follow-up 5 | Follow-up 6 | Follow-up 7 | Follow-up 8 | Follow-up 9 (Final) | Premature discontinuation | |||
Week −4 to −1 |
Week 0 |
Month 3 | Month 6 | Month 12 | Month 18 |
Month 24 | Month 30 | Month 36 | Month 42 | Month 48 | ||||
Selection criteria | X | X | ||||||||||||
Informed consent | X | |||||||||||||
Clinical history | X | |||||||||||||
Physical examination | X | |||||||||||||
BP measures | Group 1 | Office BP | X | X | X | X | X | X | X | X | X | X | X | X |
Home BP | X | X | X | X | ||||||||||
24 hours ABPM | X | X | X | X | X | X | ||||||||
Group 2 | Office BP | X | X | X | X | X | X | X | X | X | X | X | X | |
Home BP | X | X | X | X | ||||||||||
24 hours ABPM | X | X | X | X | X | X | X | X | X | X | X | |||
Blood sample for serum creatinine | X | X | ||||||||||||
Blood sample for serum creatinine, glucose, HbA1c, uric acid, Na+, K+, lipids | X | X | X | X | X | X | ||||||||
ECG | X | X | X | X | X | X | X | |||||||
Echocardiogram | X | X | X | X | X | X | ||||||||
Urine sample for microalbuminuria and albumin:creatinine ratio | X | X | X | X | X | X | X | |||||||
Ascertain achievement of BP control/adjust antihypertensive treatment if needed | X | X | X | X | X | X | X | X | X | X | X | |||
Registration of antihypertensive therapy | X | X | X | X | X | X | X | X | X | X | X | X | ||
Registration of concomitant medication | X | X | X | X | X | X | X | X | X | X | X | X | ||
Adverse events/safety evaluation | X | X | X | X | X | X | X | X | X | X | ||||
Blood sample for biobank creation | X | X |
ABPM, ambulatory blood pressure monitoring; BP, blood pressure; HbA1c, glycated haemoglobin.