This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.
Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Renal Denervation Catheter
Baker IDI Heart & Diabetes Inst
Melbourne, Victoria, Australia
blood pressure control
percentage of patients to achieve Blood Pressure (BP) target (BP \<140/90mmHg, or \<130/80mmHg in diabetic patients) at 6 months post procedure
Time frame: 6 months post procedure
number of drugs required to reach blood pressure target
number of drugs required to reach blood pressure target
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 markers of sympathetic nerve activity
Changes in Muscle Sympathetic Nerve Activity (MSNA), renal and whole body Norepinephrine (NE) spillover
Time frame: baseline to 6 months
Change in Left Ventricular Structure and Function
Change in Left Ventricular mass index, ejection fraction, diastolic filling as assessed by echocardiogram
Time frame: baseline to 6 months
Change in Quality of Life
Change in Quality of Life as assessed by relevant questionnaires
Time frame: baseline to 6 months
Serum and Urine Biochemistry
Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate (eGFR), urine albumin-to-creatinine ratio (UACR), inflammatory markers, 24hour urinary creatinine clearance, sodium, fasting glucose, fasting insulin, c-peptide, Homeostasis Model Assessment (HOMA) index, lipid profile
Time frame: baseline to 6 months
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Change in markers of arterial stiffness
Change in markers of arterial stiffness including Augmentation Index (AI) and Pulse Wave Velocity (PWV)
Time frame: baseline to 6 months