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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01438229
First received: September 19, 2011
Last updated: May 24, 2015
Last verified: February 2014

September 19, 2011
May 24, 2015
October 2011
September 2012   (final data collection date for primary outcome measure)
  • Adverse Events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    All device or procedure related adverse events
  • Office Systolic Blood Pressure Change [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Office Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01438229 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Office Diastolic BP Change [ Time Frame: Baseline to 6M ] [ Designated as safety issue: No ]
  • Office Systolic BP Change [ Time Frame: Baseline to 12M ] [ Designated as safety issue: No ]
  • Office Systolic BP Change [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: No ]
  • Office Systolic BP Change [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Office Diastolic BP Change [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
  • Office Diastolic BP Change [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: No ]
  • Office Diastolic BP Change [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • 24hr Ambulatory Systolic BP Change [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Urine Albumin to Creatinine Ratio [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Urine Albumin to Creatinine Ratio [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Urine Albumin to Creatinine Ratio [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Urine Albumin to Creatinine Ratio [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Estimated Glomular Filtration Rate [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
  • Cystatin C [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Cystatin C [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Cystatin C [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Cystatin C [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Not Provided
 
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
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.

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
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
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
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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
July 2014
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Greece
 
NCT01438229
CI-10-045-ID-HT, Arsenal
Yes
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
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
St. Jude Medical
February 2014

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