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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01865253




Registration number
NCT01865253
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 Complicated Hypertension
Scientific title
Renal Denervation for Complicated Hypertension (RDNP-2012-03)
Secondary ID [1] 0 0
1034397
Secondary ID [2] 0 0
087/12
Universal Trial Number (UTN)
Trial acronym
RDNP-2012-03
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 - Renal Denervation treatment


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

Outcomes
Primary outcome [1] 0 0
Change in average office blood pressure
Timepoint [1] 0 0
baseline to 6 months post procedure
Secondary outcome [1] 0 0
Blood pressure control
Timepoint [1] 0 0
baseline to 6 months post procedure
Secondary outcome [2] 0 0
Number of drugs required to reach target blood pressure
Timepoint [2] 0 0
baseline to 6 months post procedure
Secondary outcome [3] 0 0
Time to achieve blood pressure target
Timepoint [3] 0 0
baseline to 6 months post procedure
Secondary outcome [4] 0 0
Change in sympathetic nerve activity
Timepoint [4] 0 0
baseline to 6 months post procedure
Secondary outcome [5] 0 0
Change in left ventricular structure and function
Timepoint [5] 0 0
baseline to 6 months post procedure
Secondary outcome [6] 0 0
Change in Quality of life
Timepoint [6] 0 0
baseline to 6 months post procedure
Secondary outcome [7] 0 0
Change in serum and urine Biochemistry
Timepoint [7] 0 0
baseline to 6 months post procedure
Secondary outcome [8] 0 0
Change in markers of arterial stiffness
Timepoint [8] 0 0
baseline to 6 months

Eligibility
Key inclusion criteria
* BP =140/90 mmHg (or =130/80 mmHg for patients with diabetes)
* Intolerance to =2 antihypertensive drug classes
* Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy
* Renal artery stenosis
* Chronic Kidney Disease
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
* individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
* female participants of childbearing potential must have negative pregnancy test prior to treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
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
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
23
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
This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to:

* intolerance to antihypertensive medication
* inability to take antihypertensive medication due to planned pregnancy
* renal artery stenosis
* chronic kidney disease
* non-compliance to antihypertensive medication

A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study.

The duration of this study is 36 months.
Trial website
https://clinicaltrials.gov/study/NCT01865253
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus P 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/NCT01865253