Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients (EnligHTN-I)

Ablation-induced Renal Sympathetic Denervation Trial

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)

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

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Adelaide, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Melbourne, Victoria, Australia, 3168
      • Monash Medical Centre
• Greece
  • Athens, Greece
    • Hippokration Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: renal artery ablation; Catheter-based RF ablation in renal artery	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	All device or procedure related adverse events	24 months
Office Systolic Blood Pressure Change		Baseline to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Office Diastolic BP Change		Baseline to 6M
Office Systolic BP Change		Baseline to 12M
Office Systolic BP Change		Baseline to 18 months
Office Systolic BP Change		Baseline to 24 months
Office Diastolic BP Change		Baseline to 12 months
Office Diastolic BP Change		Baseline to 18 months
Office Diastolic BP Change		Baseline to 24 months
24hr Ambulatory Systolic BP Change	Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.	Baseline to 6 months
24hr Ambulatory Systolic BP Change	Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.	Baseline to 12 months
24hr Ambulatory Systolic BP Change	Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.	Baseline to 24 months
24hr Ambulatory Diastolic BP Change	Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.	Baseline to 6 months
24hr Ambulatory Diastolic BP Change	Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.	Baseline to 12 months
24hr Ambulatory Diastolic BP Change	Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.	Baseline to 24 months
Urine Albumin to Creatinine Ratio		Baseline
Urine Albumin to Creatinine Ratio		6 months
Urine Albumin to Creatinine Ratio		12 months
Urine Albumin to Creatinine Ratio		18 months
Urine Albumin to Creatinine Ratio		24 months
Estimated Glomular Filtration Rate	Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)	Baseline
Estimated Glomular Filtration Rate	Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)	6 months
Estimated Glomular Filtration Rate	Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)	12 months
Estimated Glomular Filtration Rate	Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)	18 months
Estimated Glomular Filtration Rate	Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)	24 months
Cystatin C		Baseline
Cystatin C		6 months
Cystatin C		12 months
Cystatin C		18 months
Cystatin C		24 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Vasilias Papademetriou, MD, First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece; Principal Investigator: Konstantinos Tsioufis, MD, First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece; Principal Investigator: Stephen Worthley, MD, Cardiovascular Investigation Unit, Royal Adelaide Hospital, Adelaide, Australia; Principal Investigator: Ian Meredith, MD, Monash Medical Centre, Melbourne, Australia; Principal Investigator: Derek Chew, MD, Flinders Medical Centre, Adelaide, AUSTRALIA

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: September 19, 2011
• First Submitted That Met QC Criteria: September 21, 2011
• First Posted (ESTIMATE): September 22, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Hypertension; Catheter-based renal artery ablation; Resistant to Conventional Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CI-10-045-ID-HT; Arsenal (OTHER: St Jude Medical)