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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01865240




Registration number
NCT01865240
Ethics application status
Date submitted
27/05/2013
Date registered
30/05/2013
Date last updated
5/11/2018

Titles & IDs
Public title
Renal Denervation for Resistant Hypertension
Scientific title
Renal Denervation for Resistant Hypertension
Secondary ID [1] 0 0
NHMRC
Secondary ID [2] 0 0
008/12
Universal Trial Number (UTN)
Trial acronym
RDNP-2012-01
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

Experimental: Renal Denervation Group - participants randomised to undergo the renal denervation procedure

No Intervention: Usual care - participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets


Treatment: Devices: Renal Denervation
Renal Denervation Catheter
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
blood pressure control
Timepoint [1] 0 0
6 months post procedure
Secondary outcome [1] 0 0
number of drugs required to reach blood pressure target
Timepoint [1] 0 0
baseline to 6 months
Secondary outcome [2] 0 0
time to achieve blood pressure target
Timepoint [2] 0 0
baseline to 6 months
Secondary outcome [3] 0 0
Change in markers of sympathetic nerve activity
Timepoint [3] 0 0
baseline to 6 months
Secondary outcome [4] 0 0
Change in Left Ventricular Structure and Function
Timepoint [4] 0 0
baseline to 6 months
Secondary outcome [5] 0 0
Change in Quality of Life
Timepoint [5] 0 0
baseline to 6 months
Secondary outcome [6] 0 0
Serum and Urine Biochemistry
Timepoint [6] 0 0
baseline to 6 months
Secondary outcome [7] 0 0
Change in markers of arterial stiffness
Timepoint [7] 0 0
baseline to 6 months

Eligibility
Key inclusion criteria
- systolic BP =140mmHg or =130mmHg for patients with diabetes

- concurrent treatment with =3 anti-hypertensive drugs
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- renal artery anatomy ineligible for treatment

- eGFR <15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)

- 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker IDI Heart & Diabetes Inst - 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
This is a study investigating the effectiveness of renal denervation in lowering blood
pressure in people whose blood pressure is not adequately controlled despite treatment with 3
or more blood pressure lowering drugs. The study is designed to compare the effects of renal
denervation to a usual care group receiving additional blood pressure lowering drugs.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01865240
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus Schlaich, MD
Address 0 0
Baker IDI Heart & Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01865240