Study of Catheter Based Renal Denervation Therapy in Hypertension (DEPART)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
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.
|
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 |
Belgium | |
Erasme Hospital | Recruiting |
Brussels, Belgium, 1070 | |
Contact: Jean Francois ARGACHA, MD 3225555214 Jean.Francois.Argacha@erasme.ulb.ac.be |
Principal Investigator: | Jean-François ARGACHA, MD | Erasme Hospital |
Responsible Party: | Jean Francois Argacha, Principal Investigator, Erasme University Hospital |
ClinicalTrials.gov Identifier: | NCT01522430 History of Changes |
Other Study ID Numbers: |
140576 |
First Posted: | January 31, 2012 Key Record Dates |
Last Update Posted: | January 31, 2012 |
Last Verified: | January 2012 |
Keywords provided by Jean Francois Argacha, Erasme University Hospital:
Resistant hypertension Renal denervation Ambulatory blood pressure |
Renal function Simplicity catheter Sham procedure |
Additional relevant MeSH terms:
Hypertension Vascular Diseases Cardiovascular Diseases |