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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02444442




Registration number
NCT02444442
Ethics application status
Date submitted
12/05/2015
Date registered
14/05/2015
Date last updated
5/11/2018

Titles & IDs
Public title
Sham Controlled Clinical Trial of Renal Denervation in Patients With Resistant Hypertension
Scientific title
The Australian SHAM Controlled Clinical Trial of Renal DeNervation in Patients With Resistant Hypertension (AUSHAM-RDN-01)
Secondary ID [1] 0 0
002/15
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Renal Denervation
Other interventions - Sham control

Active Comparator: Renal Denervation - participants randomised to undergo renal denervation

Sham Comparator: Sham control - participants randomised to undergo sham procedure


Treatment: Devices: Renal Denervation
Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries.

Other interventions: Sham control
Arterial access only. No delivery of radio frequency energy to renal arteries.

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months post procedure
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months post procedure
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
6 months post procedure
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
6 months post procedure

Eligibility
Key inclusion criteria
- systolic office BP =140mmHg and ambulatory day time average =135mmHg despite
concurrent treatment with =3 anti-hypertensive drugs
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker IDI Heart & Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02444442
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus P Schlaich, Professor
Address 0 0
Laboratory Head, Neurovascular Hypertension and Kidney Disease (Baker IDI)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Markus P Schlaich, Professor
Address 0 0
Country 0 0
Phone 0 0
+61 3 85321502
Fax 0 0
Email 0 0
Markus.Schlaich@bakeridi.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02444442