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

History of Changes

Purpose

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	Intervention	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
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	120
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility


Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


Responsible Party:	Jean Francois Argacha, Principal Investigator, Erasme University Hospital
ClinicalTrials.gov Identifier:	NCT01522430 History of Changes
Other Study ID Numbers:	140576
Study First Received:	January 25, 2012
Last Updated:	January 27, 2012
Health Authority:	Belgium: N°agreation by "Ordre des Médecins": OM021

Keywords provided by Erasme University Hospital:


Resistant hypertension Renal denervation Ambulatory blood pressure	Renal function Simplicity catheter Sham procedure

Additional relevant MeSH terms:


Hypertension Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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