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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438229
First Posted: September 22, 2011
Last Update Posted: June 19, 2015
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.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.

Condition Intervention
Hypertension Device: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ablation-induced Renal Sympathetic Denervation Trial

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 24 months ]
    All device or procedure related adverse events

  • Office Systolic Blood Pressure Change [ Time Frame: Baseline to 6 months ]

Other Outcome Measures:
  • 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 ]

Enrollment: 47
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438229


Locations
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Greece
Hippokration Hospital
Athens, Greece
Sponsors and Collaborators
St. Jude Medical
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
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01438229     History of Changes
Other Study ID Numbers: CI-10-045-ID-HT
Arsenal ( Other Identifier: St Jude Medical )
First Submitted: September 19, 2011
First Posted: September 22, 2011
Results First Submitted: April 17, 2015
Results First Posted: May 21, 2015
Last Update Posted: June 19, 2015
Last Verified: February 2014

Keywords provided by St. Jude Medical:
Catheter-based renal artery ablation
Hypertension
Resistant to Conventional Therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases