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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
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.
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.
Erasme Hospital
Brussels, Belgium
RECRUITINGglomerular filtration rate
Isotopic and 24h urine sample measure of glomerular filtration rate.
Time frame: 6 month
Ambulatory systolic and diastolic blood pressure
Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device
Time frame: 6 month
Baroreflex sensitivity
Migroneugraphy recording of sympathetic nerve activity and testing of baroreflex sensitivity
Time frame: 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
Time frame: baseline, H2, H6, 1, 3 and 6 months
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