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

• 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: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Hypertension	Device: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ablation-induced Renal Sympathetic Denervation Trial
• Study Start Date: October 2011
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: July 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures:

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

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

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

More Information

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01438229
• Other Study ID Numbers: CI-10-045-ID-HT; Arsenal ( Other Identifier: St Jude Medical )
• First Posted: September 22, 2011
• Results First Posted: May 21, 2015
• Last Update Posted: February 5, 2019
• Last Verified: February 2019

Keywords provided by Abbott Medical Devices:

Catheter-based renal artery ablation; Hypertension; Resistant to Conventional Therapy

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases