Treatment and follow-up | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week | B | 0 | 1 | 2 | 4 | 12 | 26 | 39 | 52 | 65 | 78 | 91 | 104 | 117 | 130 | 143 | 156 |
Visit | V | V1 | V2 | V3 | V4 | V5 | V6 | V7 | V8 | V9 | V10 | V11 | V12 | V13 | V14 | V15 | |
Valid informed consent | x | Randomisation in absentia and prescription produced once blood results received | |||||||||||||||
Full demographic details | x | ||||||||||||||||
Medical history | x | x | |||||||||||||||
Clinical history | x | ||||||||||||||||
Concomitant medications | x | x | x | x | x | x | x | x | |||||||||
Weight, height, waist/hip | x | x | |||||||||||||||
Physical examination | x | ||||||||||||||||
Office blood pressure measurement | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |
Home blood pressure measurement | x | x | x | x | x | x | |||||||||||
KDQOL-SF questionnaire* | x | x | x | x | x | ||||||||||||
QoL EQ-5D-5 L questionnaire* | x | x | x | x | x | ||||||||||||
ICECAP-A questionnaire* | x | x | x | x | x | ||||||||||||
QoL VAS* | x | x | x | x | x | ||||||||||||
Diary card (medication monitoring) | x | x | x | x | x | x | x | x | |||||||||
Diary card (Health Economics) | x | x | x | x | x | x | x | x | x | x | x | x | x | ||||
Adverse event monitoring | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |
Urine albumin/creatinine ratio | x | x | |||||||||||||||
12 lead ECG | x | x | |||||||||||||||
Blood tests for: | |||||||||||||||||
Full blood count | x | x | |||||||||||||||
Renal profile | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |
Liver function test and bone profile | x | x | x | x | x | ||||||||||||
Lipids | x | x | x | x | x | ||||||||||||
HbA1c | x | x | x | x | x | ||||||||||||
Fasting blood sugar | x | x | x | x | x | ||||||||||||
B-type natriuretic peptide | x | x | x | x | x | ||||||||||||
Future analysis (where applicable) | x | x | x | x | |||||||||||||
Intensively phenotyped group only | |||||||||||||||||
Pulse wave velocity | x | x | x | x | x | ||||||||||||
24-h ambulatory blood pressure estimation | x | x | x | x | x |