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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/NCT02164435




Registration number
NCT02164435
Ethics application status
Date submitted
12/06/2014
Date registered
16/06/2014
Date last updated
16/06/2014

Titles & IDs
Public title
Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation
Scientific title
Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation
Secondary ID [1] 0 0
CI-12-044-AU-HT
Universal Trial Number (UTN)
Trial acronym
RDN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncontrolled Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.

Other: Renal Denervation -


Treatment: Surgery: Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cardiac Function (evaluated by MRI)
Timepoint [1] 0 0
Baseline and 6 Months
Secondary outcome [1] 0 0
Renal Function (evaluated by MRI)
Timepoint [1] 0 0
Baseline, 6 Months and 24 Months
Secondary outcome [2] 0 0
Cardiac Function
Timepoint [2] 0 0
Baseline and 24 Months

Eligibility
Key inclusion criteria
- Subject must be able and willing to comply with the required follow-up schedule

- Therapeutic Goods Association approved indications for EnligHTN™ Renal Denervation
System

- Subject is = 18 years of age at time of consent Subject has office SBP = 160 mmHg
(except for subjects with Diabetes Mellitus who must demonstrate an office SBP of =
150 mm Hg) within 14 days of the procedure ?Subject is taking = 3 antihypertensive
medications concurrently at maximum tolerated dose (this must include one diuretic) or
subject has a documented intolerance to at least 2 out of the 4 major classes of
anti-hypertensives (ACE/ARB, CCB, Diuretics, Beta Blockers and is unable to take 3
antihypertensive drugs.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Standard CMR exclusions;

- implanted cardiac device

- intracranial metallic implants

- claustrophobia -Gadolinium-specific: estimated GFR <60 mls/min (usual clinical
cut-off is <30 mls/min).

- Adenosine-specific:

- asthma / reactive airways disease

- >first degree atrioventricular block

- concomitant use of dipyridamole or theophylline consumption of caffeine within 48
hours of proposed investigation

- EnligHTN™ Renal Denervation System exclusion criteria:

Subject has an identified cause of secondary hypertension

- Subject has an estimated GFR <45 mL/min per 1.73 m2 using the MDRD formula

- Subject has undergone prior renal angioplasty, indwelling renal stents, and/or aortic
stent grafts

- Subject has haemodynamically significant valvular heart disease

- Subject has a life expectancy less than 12 months, as determined by the PI

- Subject is participating in another clinical study Subject is pregnant, nursing, or of
childbearing potential and is not using adequate contraceptive methods

- Subject has renal arteries with diameter(s) < 4 mm in diameter

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2015
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, single centre clinical investigation looking at short (6 months) and
long term (24 months) changes in cardiac function and renal function in patients with
drug-resistant hypertension post renal sympathetic denervation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02164435
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stephen G Worthley, Prof
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
stephen.worthley@adelaide.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02164435