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

Free University of Brussels (ULB)

Status and phase: Unknown; Phase 3

Conditions: Resistant Hypertension; Ambulatory Blood Pressure; Renal Function; Renal Denervation

Treatments: Procedure: Renal angiography followed by renal sympathetic denervation; Procedure: Renal angiography alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01522430

140576

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Renal angiography followed by renal sympathetic denervation

Experimental group

Description:

Catheter based therapy for renal denervation using the Simplicity (TM) catheter (Ardian/Medtronic)

Treatment:

Procedure: Renal angiography followed by renal sympathetic denervation

Renal angiography alone

Sham Comparator group

Description:

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.

Treatment:

Procedure: Renal angiography alone