This is a study investigating the safety and usefulness of the Renal Denervation Procedure in reducing high blood pressure in people whose blood pressure is not adequately controlled despite already being treated with 2 blood pressure lowering drugs. This study is designed to compare the effects renal denervation to a usual care group.
This is a phase 4 randomised control trial of renal denervation for the treatment of uncontrolled hypertension. Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure. A total of 100 participants with uncontrolled blood pressure, treated with two blood pressure lowering medications will be recruited into the study. Patients will be assigned to one of two groups. Participants in Group 1 will be assigned to undergo the renal denervation procedure. Participants in group 2 will undergo usual care, receiving additional antihypertensive medication in an attempt to reach blood pressure targets. The duration of this study is 36 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Renal Denervation Catheter
blood pressure control
percentage of patients who achieve BP target at 6 months post intervention
Time frame: 6 months post procedure
number of drugs required to reach target blood pressure
number of drugs required to reach target blood pressure
Time frame: baseline to 6 months
time to achieve blood pressure target
time to achieve blood pressure target
Time frame: baseline to 6 months
change in sympathetic nerve activity
changes in muscle sympathetic nerve activity (MSNA), renal and whole body Noradrenaline (NA) spillover
Time frame: baseline to 6 months
Change in left ventricular function
Change in left Ventricular ejection fraction, diastolic filling
Time frame: baseline to 6 months
Change in Quality of Life
Change in Quality of life as assessed be relevant questionnaires
Time frame: baseline to 6 months
Change in Serum Biochemistry
Plasma Renin Activity, aldosterone levels, estimated Glomerular Filtration Rate(eGFR), inflammatory markers, fasting glucose, fasting insulin, C-peptide, Homeostasis Model Assessment (HOMA) index, Lipid profile
Time frame: baseline to 6 months
Change in markers of arterial stiffness
Change in markers of arterial stiffness as assessed by Augmentation Index (AI) and Pulse Wave Velocity (PWV)
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Time frame: baseline to 6 months
Change in left ventricular structure
Change in left ventricular mass index
Time frame: baseline to 6 months
Change in Urine Biochemistry
Urinary albumin creatinine ratio (UACR), 24 hour urinary creatinine clearance, sodium
Time frame: baseline to 6 months