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| ID | Type | Description | Link |
|---|---|---|---|
| 1034397 | Other Grant/Funding Number | NHMRC |
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No new participants enrolled. Protocol superseded.
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This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to:
A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study.
The duration of this study is 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental | Renal Denervation treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation | Device | Renal Denervation |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change in average office blood pressure | Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure | baseline to 6 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure control | Percentage of patients who achieved BP target at 6 months post procedure | baseline to 6 months post procedure |
| Number of drugs required to reach target blood pressure | Number of drugs required to reach target blood pressure |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baker IDI Heart & Diabetes Institute | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| baseline to 6 months post procedure |
| Time to achieve blood pressure target | Time to achieve blood pressure target | baseline to 6 months post procedure |
| Change in sympathetic nerve activity | Change in muscle sympathetic nerve activity, renal and whole body Noradrenaline (NA) spillover | baseline to 6 months post procedure |
| Change in left ventricular structure and function | Change in left Ventricular mass index, Ejection Fraction, diastolic filling | baseline to 6 months post procedure |
| Change in Quality of life | Change in Quality of life as assessed by relevant questionnaires | baseline to 6 months post procedure |
| Change in serum and urine Biochemistry | Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate(eGFR), Urinary Albumin Creatinine Ratio (UACR), inflammatory markers, 24hour urine creatinine clearance, sodium, fasting glucose, fasting insulin, c peptide, Homeostasis Model Assessment (HOMA) index, lipid profile. | baseline to 6 months post procedure |
| 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 |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |