Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Stopped early
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/study/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/study/NCT01865240