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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).