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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01438229




Registration number
NCT01438229
Ethics application status
Date submitted
19/09/2011
Date registered
22/09/2011
Date last updated
5/02/2019

Titles & IDs
Public title
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
Scientific title
Ablation-induced Renal Sympathetic Denervation Trial
Secondary ID [1] 0 0
Arsenal
Secondary ID [2] 0 0
CI-10-045-ID-HT
Universal Trial Number (UTN)
Trial acronym
EnligHTN-I
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 - St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)

Experimental: renal artery ablation - Catheter-based RF ablation in renal artery


Treatment: Devices: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)
Catheter-based RF ablation in renal artery
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Office Systolic Blood Pressure Change
Timepoint [2] 0 0
Baseline to 6 months

Eligibility
Key inclusion criteria
* Office systolic blood pressure that remains =160 mmHg (=150 mmHg for patient with type 2 diabetes) despite the stable use of =3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
* Age =18 and =80 years old
* Able and willing to provide written informed consent to participate in the study
* Able and willing to comply with the required follow-up schedule
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior renal artery intervention (balloon angioplasty or stenting)
* Evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in either renal artery
* Multiple main renal arteries in either kidney
* Main renal arteries <4 mm in diameter or <20 mm in length
* eGFR of <45 mL/min per 1.73 m2 using the MDRD formula
* Type 1 diabetes
* Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure)
* Others

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Greece
State/province [1] 0 0
Athens

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.
Trial website
https://clinicaltrials.gov/study/NCT01438229
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vasilias Papademetriou, MD
Address 0 0
First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece
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/study/NCT01438229