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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01438229
Recruitment Status : Completed
First Posted : September 22, 2011
Results First Posted : May 21, 2015
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE September 19, 2011
First Posted Date  ICMJE September 22, 2011
Results First Submitted Date  ICMJE April 17, 2015
Results First Posted Date  ICMJE May 21, 2015
Last Update Posted Date February 5, 2019
Study Start Date  ICMJE October 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
  • Adverse Events [ Time Frame: 24 months ]
    All device or procedure related adverse events
  • Office Systolic Blood Pressure Change [ Time Frame: Baseline to 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2011)
  • All adverse events [ Time Frame: 6 months ]
  • Office Blood Pressure [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT01438229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 5, 2015)
  • Office Diastolic BP Change [ Time Frame: Baseline to 6M ]
  • Office Systolic BP Change [ Time Frame: Baseline to 12M ]
  • Office Systolic BP Change [ Time Frame: Baseline to 18 months ]
  • Office Systolic BP Change [ Time Frame: Baseline to 24 months ]
  • Office Diastolic BP Change [ Time Frame: Baseline to 12 months ]
  • Office Diastolic BP Change [ Time Frame: Baseline to 18 months ]
  • Office Diastolic BP Change [ Time Frame: Baseline to 24 months ]
  • 24hr Ambulatory Systolic BP Change [ Time Frame: Baseline to 6 months ]
    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.
  • 24hr Ambulatory Systolic BP Change [ Time Frame: Baseline to 12 months ]
    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.
  • 24hr Ambulatory Systolic BP Change [ Time Frame: Baseline to 24 months ]
    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.
  • 24hr Ambulatory Diastolic BP Change [ Time Frame: Baseline to 6 months ]
    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.
  • 24hr Ambulatory Diastolic BP Change [ Time Frame: Baseline to 12 months ]
    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.
  • 24hr Ambulatory Diastolic BP Change [ Time Frame: Baseline to 24 months ]
    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.
  • Urine Albumin to Creatinine Ratio [ Time Frame: Baseline ]
  • Urine Albumin to Creatinine Ratio [ Time Frame: 6 months ]
  • Urine Albumin to Creatinine Ratio [ Time Frame: 12 months ]
  • Urine Albumin to Creatinine Ratio [ Time Frame: 18 months ]
  • Urine Albumin to Creatinine Ratio [ Time Frame: 24 months ]
  • Estimated Glomular Filtration Rate [ Time Frame: Baseline ]
    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)
  • Estimated Glomular Filtration Rate [ Time Frame: 6 months ]
    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)
  • Estimated Glomular Filtration Rate [ Time Frame: 12 months ]
    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)
  • Estimated Glomular Filtration Rate [ Time Frame: 18 months ]
    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)
  • Estimated Glomular Filtration Rate [ Time Frame: 24 months ]
    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)
  • Cystatin C [ Time Frame: Baseline ]
  • Cystatin C [ Time Frame: 6 months ]
  • Cystatin C [ Time Frame: 12 months ]
  • Cystatin C [ Time Frame: 18 months ]
  • Cystatin C [ Time Frame: 24 months ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
Official Title  ICMJE Ablation-induced Renal Sympathetic Denervation Trial
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: renal artery ablation
Catheter-based RF ablation in renal artery
Intervention: Device: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2012)
47
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2011)
60
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01438229
Other Study ID Numbers  ICMJE CI-10-045-ID-HT
Arsenal ( Other Identifier: St Jude Medical )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Abbott Medical Devices
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP