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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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) - MRI Indices of Cardiac Function
Myocardial mass and myocardial fibrosis
Atrial and ventricular ejection function
Myocardial perfusion
Arterial distensibility
Timepoint [1] 0 0
Baseline and 6 Months
Secondary outcome [1] 0 0
Renal Function (evaluated by MRI) - MRI Indices of Renal Function:
Renal blood flow
Renal perfusion
Urinary protein
Timepoint [1] 0 0
Baseline, 6 Months and 24 Months
Secondary outcome [2] 0 0
Cardiac Function - MRI Indices of Cardiac Function
Myocardial mass and myocardial fibrosis
Atrial and ventricular ejection function
Myocardial perfusion
Arterial distensibility
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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/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/show/NCT02164435