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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Renal Denervation; Other: Sham control

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Baker IDI Heart & Diabetes Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Baker Heart and Diabetes Institute
• Investigators: Principal Investigator: Markus P Schlaich, Professor, Laboratory Head, Neurovascular Hypertension and Kidney Disease (Baker IDI)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimated): May 14, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Blood pressure; Cardiovascular risk; Target organ damage; Sympathetic activity; Renal denervation; Non-compliance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 002/15