Study of Catheter Based Renal Denervation Therapy in Hypertension (DEPART)
|ClinicalTrials.gov Identifier: NCT01522430|
Recruitment Status : Unknown
Verified January 2012 by Jean Francois Argacha, Erasme University Hospital.
Recruitment status was: Recruiting
First Posted : January 31, 2012
Last Update Posted : January 31, 2012
The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation:
- reduces daytime ambulatory blood pressure,
- improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.
|Condition or disease||Intervention/treatment||Phase|
|Resistant Hypertension Renal Denervation Ambulatory Blood Pressure Renal Function||Procedure: Renal angiography followed by renal sympathetic denervation Procedure: Renal angiography alone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2016|
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.
- glomerular filtration rate [ Time Frame: 6 month ]Isotopic and 24h urine sample measure of glomerular filtration rate.
- Ambulatory systolic and diastolic blood pressure [ Time Frame: 6 month ]Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device
- Baroreflex sensitivity [ Time Frame: 6 month ]Migroneugraphy recording of sympathetic nerve activity and testing of baroreflex sensitivity
- Biological markers of acute kidney injury [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522430
|Contact: ARGACHA Jean francois, MD||33225555214||Jean.Francois.Argacha@erasme.ulb.ac.be|
|Brussels, Belgium, 1070|
|Contact: Jean Francois ARGACHA, MD 3225555214 Jean.Francois.Argacha@erasme.ulb.ac.be|
|Principal Investigator:||Jean-François ARGACHA, MD||Erasme Hospital|