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The purpose of this study is to assess the efficacy of catheter-based renal denervation in reducing blood pressure in patients with resistant hypertension compared to a sham procedure. Patients will be randomized to RDN or sham control in a 2:1 ratio. All participants will be switched to a single pill triple combination treatment prior to the procedure.
A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35 patients in the sham control arm.
The duration of this study is 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Active Comparator | participants randomised to undergo renal denervation |
|
| Sham control | Sham Comparator | participants randomised to undergo sham procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation | Device | Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ambulatory systolic blood pressure between groups | Difference in mean ambulatory systolic daytime blood pressure between RDN group and sham-control group at 6 month follow up. | 6 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean 24h systolic blood pressure between groups | Change in mean 24h systolic blood pressure between RDN group and sham-control group at 6 month follow up. | 6 months post procedure |
| Change in mean night time systolic blood pressure between groups |
| Measure | Description | Time Frame |
|---|---|---|
| Change in percentage of patients achieving BP target between groups | Change in percentage of patients achieving BP target between groups | 6 months post procedure |
| Change in percentage of patients with an ambulatory systolic BP reduction ≥5mmHg between groups |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus P Schlaich, Professor | Laboratory Head, Neurovascular Hypertension and Kidney Disease (Baker IDI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baker IDI Heart & Diabetes Institute | Melbourne | Victoria | 3004 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34806762 | Derived | Pisano A, Iannone LF, Leo A, Russo E, Coppolino G, Bolignano D. Renal denervation for resistant hypertension. Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD011499. doi: 10.1002/14651858.CD011499.pub3. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Sham control | Other | Arterial access only. No delivery of radio frequency energy to renal arteries. |
|
Change in mean night time systolic blood pressure between RDN group and sham-control group at 6 month follow up. |
| 6 months post procedure |
| Change in mean office systolic blood pressure between groups | Change in mean office systolic blood pressure between RDN group and sham-control group at 6 month follow up. | 6 months post procedure |
Change in percentage of patients with an ambulatory systolic BP reduction ≥5mmHg between groups
| 6 months post procedure |
| Change in percentage of patients with an office systolic BP reduction ≥10mmHg between groups | Change in percentage of patients with an office systolic BP reduction ≥10mmHg between groups | 6 months post procedure |
| Change of sympathetic nerve activity between groups | Change of sympathetic nerve activity (MSNA, renal and whole body NE spillover) between groups | 6 months post procedure |
| Change in left ventricular function between groups | Change in left ventricular function (LV mass index, ejection fraction, diastolic filling) between groups | 6 months post procedure |
| Change in Serum Biochemistry between groups | 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 between groups | 6 months post procedure |
| Change in Urine Biochemistry between groups | Urinary albumin creatinine ratio (UACR), 24 hour urinary creatinine clearance, sodium between groups | 6 months post procedure |
| Change in Quality of Life between groups | Change in Quality of life as assessed by relevant questionnaires between groups | 6 months post procedure |
| Change in cognitive function between groups | Change in cognitive function as assessed by relevant questionnaires and assessment tools between groups | 6 months post procedure |
| Change in microRNA expression between groups | Change in microRNA expression as assessed by relevant assays between groups | 6 months post procedure |