Sham Controlled Clinical Trial of Renal Denervation in Patients With Resistant Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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The Australian SHAM Controlled Clinical Trial of Renal DeNervation in Patients With Resistant Hypertension (AUSHAM-RDN-01)

Conditions
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Hypertension

Intervention / Treatment
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* Device: Renal Denervation
* Other: Sham control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: systolic office BP ≥140mmHg and ambulatory day time average ≥135mmHg despite concurrent treatment with ≥3 anti-hypertensive drugs Exclusion Criteria: renal artery anatomy ineligible for treatment eGFR <15mL/min/1.73m2 (using MDRD calculation) myocardial infarction, unstable angina or cerebrovascular accident within 3 months of screening visit life expectancy of <12 months 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Renal Denervation<br>participants randomised to undergo renal denervation | Device: Renal Denervation<br>* Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries.<br>|
| Sham Comparator: Sham control<br>participants randomised to undergo sham procedure | Other: Sham control<br>* Arterial access only. No delivery of radio frequency energy to renal arteries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sympathetic activity, Renal denervation, Blood pressure, Cardiovascular risk, Target organ damage, Non-compliance