Renal Denervation for Resistant Hypertension

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Renal Denervation for Resistant Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Device: Renal Denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: systolic BP ≥140mmHg or ≥130mmHg for patients with diabetes concurrent treatment with ≥3 anti-hypertensive drugs Exclusion Criteria: renal artery anatomy ineligible for treatment eGFR <15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation) female participants of childbearing potential must have negative pregnancy test prior to treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation Group<br>participants randomised to undergo the renal denervation procedure | Device: Renal Denervation<br>* Renal Denervation Catheter<br>* Other names: Symplicity Renal Denervation Catheter;|
| No Intervention: Usual care<br>participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of drugs required to reach blood pressure target | number of drugs required to reach blood pressure target | baseline to 6 months | 
| time to achieve blood pressure target | time to achieve blood pressure target | 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 | 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 | baseline to 6 months | 
| Change in Quality of Life | Change in Quality of Life as assessed by relevant questionnaires | 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 | baseline to 6 months | 
| Change in markers of arterial stiffness | Change in markers of arterial stiffness including Augmentation Index (AI) and Pulse Wave Velocity (PWV) | baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal denervation, blood pressure, cardiovascular risk, target organ damage, sympathetic activity