Study of Catheter Based Renal Denervation Therapy in Hypertension

Phase 3

• Conditions: Renal Function; Resistant Hypertension; Renal Denervation; Ambulatory Blood Pressure
• Interventions: Procedure: Renal angiography followed by renal sympathetic denervation; Procedure: Renal angiography alone

• Registration Number: NCT01522430
• Lead Sponsor: Erasme University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-27
• Last Update Submitted: 2012-01-27
• Study First Posted: 2012-01-31
• Last Update Posted: 2012-01-31
• Primary Completion: 2014-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal angiography followed by renal sympathetic denervation	Renal angiography followed by renal sympathetic denervation	Catheter based therapy for renal denervation using the Simplicity (TM) catheter (Ardian/Medtronic)
Renal angiography alone	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussels, Belgium