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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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01865253