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Table 1 BARACK D patient visit schedule

From: Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial–a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular outcomes versus routine care alone: study protocol for a randomized controlled trial

  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
  1. *Kidney Disease Quality of Life-Short Form (KDQOL-SF), Quality of Life EuroQol, 5 Dimensions, 5 Levels (QoL EQ-5D-5 L) ICEpop CAPability measure for Adults (ICECAP-A), Quality of Life Visual Analogue Scale (QoL VAS).