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

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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
Sponsor:
Information provided by (Responsible Party):
Jean Francois Argacha, Erasme University Hospital

Study Description
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Brief Summary:

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.

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 Design
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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
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. glomerular filtration rate [ Time Frame: 6 month ]
    Isotopic and 24h urine sample measure of glomerular filtration rate.

  2. Ambulatory systolic and diastolic blood pressure [ Time Frame: 6 month ]
    Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device


Secondary Outcome Measures :
  1. Baroreflex sensitivity [ Time Frame: 6 month ]
    Migroneugraphy recording of sympathetic nerve activity and testing of baroreflex sensitivity

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Contact: ARGACHA Jean francois, MD 33225555214 Jean.Francois.Argacha@erasme.ulb.ac.be

Locations
Belgium
Erasme Hospital Recruiting
Brussels, Belgium, 1070
Contact: Jean Francois ARGACHA, MD    3225555214    Jean.Francois.Argacha@erasme.ulb.ac.be   
Sponsors and Collaborators
Erasme University Hospital
Investigators
Principal Investigator: Jean-François ARGACHA, MD Erasme Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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