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

Hypertension Clinical Trial

— EnligHTN-I  

Official title:

Ablation-induced Renal Sympathetic Denervation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438229
• Other study ID #: CI-10-045-ID-HT
• Secondary ID: Arsenal
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: July 2014

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide	South Australia
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Monash Medical Centre	Melbourne	Victoria
Greece	Hippokration Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Office Diastolic BP Change		Baseline to 6M
Other	Office Systolic BP Change		Baseline to 12M
Other	Office Systolic BP Change		Baseline to 18 months
Other	Office Systolic BP Change		Baseline to 24 months
Other	Office Diastolic BP Change		Baseline to 12 months
Other	Office Diastolic BP Change		Baseline to 18 months
Other	Office Diastolic BP Change		Baseline to 24 months
Other	24hr Ambulatory Systolic BP Change	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.	Baseline to 6 months
Other	24hr Ambulatory Systolic BP Change	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.	Baseline to 12 months
Other	24hr Ambulatory Systolic BP Change	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.	Baseline to 24 months
Other	24hr Ambulatory Diastolic BP Change	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.	Baseline to 6 months
Other	24hr Ambulatory Diastolic BP Change	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.	Baseline to 12 months
Other	24hr Ambulatory Diastolic BP Change	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.	Baseline to 24 months
Other	Urine Albumin to Creatinine Ratio		Baseline
Other	Urine Albumin to Creatinine Ratio		6 months
Other	Urine Albumin to Creatinine Ratio		12 months
Other	Urine Albumin to Creatinine Ratio		18 months
Other	Urine Albumin to Creatinine Ratio		24 months
Other	Estimated Glomular Filtration Rate	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)	Baseline
Other	Estimated Glomular Filtration Rate	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)	6 months
Other	Estimated Glomular Filtration Rate	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)	12 months
Other	Estimated Glomular Filtration Rate	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)	18 months
Other	Estimated Glomular Filtration Rate	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 months
Other	Cystatin C		Baseline
Other	Cystatin C		6 months
Other	Cystatin C		12 months
Other	Cystatin C		18 months
Other	Cystatin C		24 months
Primary	Adverse Events	All device or procedure related adverse events	24 months
Primary	Office Systolic Blood Pressure Change		Baseline to 6 months