Study of Catheter Based Renal Denervation Therapy in Hypertension (DEPART)

DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY

The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation:

1. reduces daytime ambulatory blood pressure,
2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.

Study Overview

• Status: Unknown
• Conditions: Renal Function; Resistant Hypertension; Ambulatory Blood Pressure; Renal Denervation
• Intervention / Treatment: Procedure: Renal angiography followed by renal sympathetic denervation; Procedure: Renal angiography alone

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Recruiting
    • Erasme Hospital
    • Contact: Jean Francois ARGACHA, MD; Phone Number: 3225555214; Email: Jean.Francois.Argacha@erasme.ulb.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• They have a mandatory > 3 antihypertensive medication therapy, including a thiazide or a loop diuretic (according to the patient's renal function, unless documented side-effects) and at least one attempt to treat with spironolactone, given at usual recommended dose since at least 8 weeks, before inclusion,
• A mandatory check list of secondary cause of hypertension has been excluded
• They succeed the pill count test.
• They have a mandatory ambulatory blood pressure monitoring before inclusion with at least 70% of valid readings during daytime (08:00 am 08:00 pm, using a sampling frequency of 20 minutes, only devices validated according to http://www.dableducational.org are permitted), where daytime ambulatory blood pressure of systolic and/or diastolic blood pressure exceeds 135 mmHg and/or 85 mmHg, respectively. Daytime ambulatory blood pressure of systolic and/or diastolic blood pressure below 135 mmHg and/or 85 mmHg, respectively, is acceptable for inclusion in the study if the patient takes four or more antihypertensive medication (3).

Exclusion Criteria:

• Patients with an eGFR <30ml/min/m² are excluded,
• patients with known renal atherosclerotic lesions,
• previous procedures in the renal arteries,
• known unsuitable anatomy for the procedure,
• previous nephrectomy,
• contrast agent allergy,
• hyperthyroidia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal angiography followed by renal sympathetic denervation; Catheter based therapy for renal denervation using the Simplicity (TM) catheter (Ardian/Medtronic)	Procedure: Renal angiography followed by renal sympathetic denervation; Radiofrequency catheter based therapy for renal denervation: Symplicity catheter will be advanced into the renal artery and connected to a radiofrequency generator. As previously described, four-to-six discrete, low-power radio frequency treatments will be applied along the length of both main renal arteries. At least four radiofrequency applications will be delivered in each renal artery, unless this is not feasible for anatomical reasons.
Sham Comparator: Renal angiography alone; Renal selective angiography using standardized method: Local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized.	Procedure: Renal angiography alone; Procedure will start with a local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery, which allows a minimal risk of bleeding to the patient. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glomerular filtration rate	Isotopic and 24h urine sample measure of glomerular filtration rate.	6 month
Ambulatory systolic and diastolic blood pressure	Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baroreflex sensitivity	Migroneugraphy recording of sympathetic nerve activity and testing of baroreflex sensitivity	6 month
Biological markers of acute kidney injury	Urine sample for NGAL, L-FABP and Cystatine C at baseline, H2, H6, 1, 3 and 6 months	baseline, H2, H6, 1, 3 and 6 months

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Jean-François ARGACHA, MD, Erasme Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: January 25, 2012
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (Estimate): January 31, 2012

Study Record Updates

• Last Update Posted (Estimate): January 31, 2012
• Last Update Submitted That Met QC Criteria: January 27, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Renal function; Renal denervation; Ambulatory blood pressure; Resistant hypertension; Sham procedure; Simplicity catheter
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 140576