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

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

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.

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