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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Erasme University Hospital
Sponsor:
Information provided by (Responsible Party):
Jean Francois Argacha, Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT01522430
First received: January 25, 2012
Last updated: January 27, 2012
Last verified: January 2012

January 25, 2012
January 27, 2012
January 2012
December 2014   (final data collection date for primary outcome measure)
  • glomerular filtration rate [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    Isotopic and 24h urine sample measure of glomerular filtration rate.
  • Ambulatory systolic and diastolic blood pressure [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device
Same as current
Complete list of historical versions of study NCT01522430 on ClinicalTrials.gov Archive Site
  • Baroreflex sensitivity [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Urine sample for NGAL, L-FABP and Cystatine C at baseline, H2, H6, 1, 3 and 6 months
Same as current
Not Provided
Not Provided
 
Study of Catheter Based Renal Denervation Therapy in Hypertension
DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Resistant Hypertension
  • Renal Denervation
  • Ambulatory Blood Pressure
  • Renal Function
  • 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.
  • 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.
  • Experimental: Renal angiography followed by renal sympathetic denervation
    Catheter based therapy for renal denervation using the Simplicity (TM) catheter (Ardian/Medtronic)
    Intervention: Procedure: Renal angiography followed by renal sympathetic denervation
  • 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.
    Intervention: Procedure: Renal angiography alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2016
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: ARGACHA Jean francois, MD 33225555214 Jean.Francois.Argacha@erasme.ulb.ac.be
Belgium
 
NCT01522430
140576
Yes
Jean Francois Argacha, Erasme University Hospital
Erasme University Hospital
Not Provided
Principal Investigator: Jean-François ARGACHA, MD Erasme Hospital
Erasme University Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP