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Completed

NCT Number: NCT01438229

Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Flinders Medical Centre, Adelaide, South Australia, Australia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Catheter-based RF ablation in renal artery

Primary outcomes

  1. Adverse Events

    Time frame: 24 months

    All device or procedure related adverse events

  2. Office Systolic Blood Pressure Change

    Time frame: Baseline to 6 months

Other outcomes

  1. Office Diastolic BP Change

    Time frame: Baseline to 6M

  2. Office Systolic BP Change

    Time frame: Baseline to 12M

  3. Office Systolic BP Change

    Time frame: Baseline to 18 months

  4. Office Systolic BP Change

    Time frame: Baseline to 24 months

  5. Office Diastolic BP Change

    Time frame: Baseline to 12 months

  6. Office Diastolic BP Change

    Time frame: Baseline to 18 months

  7. Office Diastolic BP Change

    Time frame: Baseline to 24 months

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Urine Albumin to Creatinine Ratio

    Time frame: Baseline

  15. Urine Albumin to Creatinine Ratio

    Time frame: 6 months

  16. Urine Albumin to Creatinine Ratio

    Time frame: 12 months

  17. Urine Albumin to Creatinine Ratio

    Time frame: 18 months

  18. Urine Albumin to Creatinine Ratio

    Time frame: 24 months

  19. 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)

  20. 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)

  21. 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)

  22. 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)

  23. 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)

  24. Cystatin C

    Time frame: Baseline

  25. Cystatin C

    Time frame: 6 months

  26. Cystatin C

    Time frame: 12 months

  27. Cystatin C

    Time frame: 18 months

  28. Cystatin C

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Ablation-induced Renal Sympathetic Denervation Trial

Acronym: EnligHTN-I

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Sep 22, 2011
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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