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Table 1 The schedule of enrolment, interventions, and assessments

From: Effect of focused power ultrasound-mediated perirenal fat modification on primary hypertension: protocol of a multicenter, randomized, double-blinded, sham-controlled study

 

Study period

 

Enrolment

Allocation

Post-allocation

Close-out

Timepoint

− 14 days

Day 0

Day 1

Day 14

Day 30

Day 90

Enrolment:

 Eligibility screen

X

     

 Informed consent

X

     

Interventions:

 PFM

 

X

    

 Sham-control

 

X

    

Assessments:

 Office BP measurement

X

 

X

X

X

X

 24-h ambulatory BP measurement

X

 

X

 

X

X

 History of diseases

X

     

 Physical examinations

X

   

X

X

 Drugs use record

X

  

X

X

X

 Antihypertensive drugs concentration tests

X

   

X

X

 Blood routine

X

 

X

 

X

X

 Biochemical test

X

 

X

 

X

X

 C-reactive protein

X

 

X

   

 Biomarkers of acute renal injury

X

 

X

   

 ECG

X

 

X

 

X

X

 Renal and renal artery ultrasound

X

 

X

 

X

X

 Carotid ultrasound

X

 

X

 

X

X

 Cardiac ultrasound

X

     

 MR imaging of perirenal fat

X

   

X

X

 Functional MR imaging of hypothalamus

X

   

X

X

  1. PFM, perirenal fat modification. BP, blood pressure, ECG, electrocardiogram MR, magnetic resonance