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| ID | Type | Description | Link |
|---|---|---|---|
| 1034397 | Other Grant/Funding Number | NHMRC |
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No participants enrolled into study and protocol has been superseded
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets | |
| Renal Denervation Group | Experimental | participants randomised to undergo the renal denervation procedure |
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| 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 who achieve BP target at 6 months post intervention | 6 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| number of drugs required to reach target blood pressure | number of drugs required to reach target blood pressure | 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 P Schlaich, MD | Baker IDI Heart & Diabetes Institute | Principal Investigator |
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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 sympathetic nerve activity | changes in muscle sympathetic nerve activity (MSNA), renal and whole body Noradrenaline (NA) spillover | baseline to 6 months |
| Change in left ventricular function | Change in left Ventricular ejection fraction, diastolic filling | baseline to 6 months |
| Change in Quality of Life | Change in Quality of life as assessed be relevant questionnaires | 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 | 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) | baseline to 6 months |
| Change in left ventricular structure | Change in left ventricular mass index | baseline to 6 months |
| Change in Urine Biochemistry | Urinary albumin creatinine ratio (UACR), 24 hour urinary creatinine clearance, sodium | baseline to 6 months |