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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/NCT00483808
Registration number
NCT00483808
Ethics application status
Date submitted
5/06/2007
Date registered
7/06/2007
Date last updated
5/11/2013
Titles & IDs
Public title
Renal Denervation in Patients With Refractory Hypertension
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Scientific title
Renal Denervation in Patients With Refractory Hypertension
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Secondary ID [1]
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TP-015 & TP-038
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
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Condition category
Condition code
Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Ardian Symplicity™ Catheter
Experimental: Denervation - Renal denervation using the Symplicty Catheter
Treatment: Devices: Ardian Symplicity™ Catheter
Renal denervation using the Symplicity Catheter
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To provide confirmation that renal denervation is safe and feasible.
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Assessment method [1]
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Timepoint [1]
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3 years
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Secondary outcome [1]
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Evidence of renal denervation; indication of physiologic response; assessment of device performance.
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Assessment method [1]
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Timepoint [1]
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3 years
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Eligibility
Key inclusion criteria
- >= 18 years of age.
- a systolic blood pressure of 160 mmHg or greater.
- receiving and adhering to full doses of an appropriate antihypertensive drug regimen
for a minimum of two weeks prior to screening.
- agrees to have the study procedure(s) performed and additional procedures and
evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical
examination.
- competent and willing to provide written, informed consent to participate in this
clinical study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- renal arterial abnormalities
- end stage renal disease requiring dialysis or renal transplant
- serum Cr > 3, or calculated GFR < 45 ml/min
- has experienced MI, unstable angina pectoris, or CVA with 6 months
- others
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Study design
Purpose of the study
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2013
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Sample size
Target
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Accrual to date
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Final
73
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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St. Vincent's Hospital - Fitzroy
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3065 - Fitzroy
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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Poland
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State/province [1]
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Krakow
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Medtronic Vascular
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To investigate the clinical utility of renal denervation in the treatment of refractory
hypertension.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00483808
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Henry Krum, MBBS,PhD
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Address
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The Alfred Hospital and Monash University, Melbourne, VIC, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00483808
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