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| ID | Type | Description | Link |
|---|---|---|---|
| NHMRC | Other Grant/Funding Number | 1034397 |
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No new participants enrolled. Protocol has been superseded
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation Group | Experimental | participants randomised to undergo the renal denervation procedure |
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| Usual care | No Intervention | participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation | Device | Renal Denervation Catheter |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Schlaich, MD | Baker IDI Heart & Diabetes Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baker IDI Heart & Diabetes Inst | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |