Table 3 Data collection schedule.

From: A Randomized trial assessing Efficacy and safety of Mineralocorticoid receptor Antagonist therapy compared to Standard antihypertensive Therapy in hypErtension with low Renin (REMASTER): rationale and study design

  

Week

–6

–2

0

6

12

24

36

48

Enrolment

Informed consent

x

       

DRCx2, PACx2, ARR x2, UEC, BhCG (if relevant), HBA1C, PTH, calcium, vitamin D, TSH, plasma metanephrines, 24-h urinary cortisol, and saline suppression test.

 

x

      

Randomization

  

x

     

Intervention

Active: MRA

   

Control: standard antihypertensives

   

Assessment

BMI, age, sex, ethnicity, smoking status, ethanol intake, OSA screening

  

x

    

x (weight only)

Mean clinic blood pressure

x

 

x

x

x

x

x

x

PAC, DRC, ARR, UEC

   

x

x

x

x

x

Fasting glucose, fasting lipid profile, liver function tests

 

x

     

x

PTH, calcium, vitamin D

       

x

24-h urine sodium, potassium, calcium, aldosterone, and albumin

 

x

     

x

24-h urine steroid profile

 

x

      

FBE, CRP, BNP

 

x

     

x

Plasma steroid profile

 

x

      

Plasma and urine biobank sample

 

x

     

x

Monocyte gene expression profile

 

x

      

ABPM

  

x

    

x

TTE

  

x

    

x

Endothelial function

  

x

    

x

QOL (SF-36 questionnaire)

  

x

    

x

Compliance assessment

   

x

x

x

x

x

Adverse effect monitoring

   

x

x

x

x

x

  1. ABPM ambulatory blood pressure monitoring, ARR aldosterone to renin ratio, BhCG beta-human chorionic gonadotrophin, BMI body mass index, BNP brain natriuretic peptide, CRP C-reactive protein, FBE full blood examination, GLS global longitudinal strain, HBA1c glycosylated hemoglobin, LFT liver function tests, LVMI left ventricular mass index, MRA mineralocorticoid receptor antagonists, OSA obstructive sleep apnea, PAC plasma aldosterone concentration, DRC direct renin concentration, PTH parathyroid stimulating hormone, SST saline suppression test, TSH thyroid-stimulating hormone, TTE trans-thoracic echocardiogram.
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