Clinical trial NCT01438229: Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
Official title: Ablation-induced Renal Sympathetic Denervation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Catheter-based renal artery ablation
Hypertension
Resistant to Conventional Therapy
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-09-22
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.

Detailed description: Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal Denervation System in the treatment of patients with resistant hypertension.

Safety Marker

* All adverse events

Efficacy Marker

* Office blood pressure

Eligibility criteria: 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

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

Primary outcomes:
measure: Adverse Events
timeFrame: 24 months
measure: Office Systolic Blood Pressure Change
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
measure: Office Diastolic BP Change
timeFrame: Baseline to 6M
measure: Office Systolic BP Change
timeFrame: Baseline to 12M
measure: Office Systolic BP Change
timeFrame: Baseline to 18 months
measure: Office Systolic BP Change
timeFrame: Baseline to 24 months
measure: Office Diastolic BP Change
timeFrame: Baseline to 12 months
measure: Office Diastolic BP Change
timeFrame: Baseline to 18 months
measure: Office Diastolic BP Change
timeFrame: Baseline to 24 months
measure: 24hr Ambulatory Systolic BP Change
timeFrame: Baseline to 6 months
measure: 24hr Ambulatory Systolic BP Change
timeFrame: Baseline to 12 months
measure: 24hr Ambulatory Systolic BP Change
timeFrame: Baseline to 24 months
measure: 24hr Ambulatory Diastolic BP Change
timeFrame: Baseline to 6 months
measure: 24hr Ambulatory Diastolic BP Change
timeFrame: Baseline to 12 months
measure: 24hr Ambulatory Diastolic BP Change
timeFrame: Baseline to 24 months
measure: Urine Albumin to Creatinine Ratio
timeFrame: Baseline
measure: Urine Albumin to Creatinine Ratio
timeFrame: 6 months
measure: Urine Albumin to Creatinine Ratio
timeFrame: 12 months
measure: Urine Albumin to Creatinine Ratio
timeFrame: 18 months
measure: Urine Albumin to Creatinine Ratio
timeFrame: 24 months
measure: Estimated Glomular Filtration Rate
timeFrame: Baseline
measure: Estimated Glomular Filtration Rate
timeFrame: 6 months
measure: Estimated Glomular Filtration Rate
timeFrame: 12 months
measure: Estimated Glomular Filtration Rate
timeFrame: 18 months
measure: Estimated Glomular Filtration Rate
timeFrame: 24 months
measure: Cystatin C
timeFrame: Baseline
measure: Cystatin C
timeFrame: 6 months
measure: Cystatin C
timeFrame: 12 months
measure: Cystatin C
timeFrame: 18 months
measure: Cystatin C
timeFrame: 24 months
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Athens
country: Greece
facility: Hippokration Hospital
Study officials:
affiliation: First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece
name: Vasilias Papademetriou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece
name: Konstantinos Tsioufis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Investigation Unit, Royal Adelaide Hospital, Adelaide, Australia
name: Stephen Worthley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash Medical Centre, Melbourne, Australia
name: Ian Meredith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Flinders Medical Centre, Adelaide, AUSTRALIA
name: Derek Chew, MD
role: PRINCIPAL_INVESTIGATOR
References: