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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/NCT00888433




Registration number
NCT00888433
Ethics application status
Date submitted
24/04/2009
Date registered
27/04/2009
Date last updated
20/05/2015

Titles & IDs
Public title
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Scientific title
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Secondary ID [1] 0 0
TP-058
Universal Trial Number (UTN)
Trial acronym
HTN-2
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: Devices - Renal Denervation (Symplicity® Renal Denervation System)

Experimental: Renal Denervation - Renal Denervation and maintenance of anti-hypertensive medications

No Intervention: Control - Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months


Treatment: Devices: Renal Denervation (Symplicity® Renal Denervation System)
Catheter-based renal denervation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Office Systolic Blood Pressure Reduction
Timepoint [1] 0 0
Baseline to 6 months

Eligibility
Key inclusion criteria
- systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);

- on 3 or more antihypertensive medications

- >= 18 and =< 85 years of age.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- renal artery abnormalities

- eGFR < 45mL/min

- MI, angina, CVA within 6 months

- Type 1 diabetes

- ICD or pacemaker, or any other metallic implant not compatible with MRI

- others

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
Germany
State/province [4] 0 0
Bad Krozingen
Country [5] 0 0
Germany
State/province [5] 0 0
Cologne
Country [6] 0 0
Germany
State/province [6] 0 0
Dusseldorf
Country [7] 0 0
Germany
State/province [7] 0 0
Erlangen
Country [8] 0 0
Germany
State/province [8] 0 0
Essen
Country [9] 0 0
Germany
State/province [9] 0 0
Frankfurt
Country [10] 0 0
Germany
State/province [10] 0 0
Homburg
Country [11] 0 0
Germany
State/province [11] 0 0
Leipzig
Country [12] 0 0
Germany
State/province [12] 0 0
Leubeck
Country [13] 0 0
Latvia
State/province [13] 0 0
Riga
Country [14] 0 0
Poland
State/province [14] 0 0
Warsaw
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Switzerland
State/province [16] 0 0
Zurich
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Canterbury
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Glasgow
Country [19] 0 0
United Kingdom
State/province [19] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Vascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
An international, multi-center, prospective, randomized, controlled study of the safety and
effectiveness of renal denervation in patients with uncontrolled hypertension.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00888433
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Murray Esler, MBBS
Address 0 0
The 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/ct2/show/NCT00888433