search
Back to results

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

Primary Purpose

Resistant Hypertension, Renal Denervation, Ambulatory Blood Pressure

Status
Unknown status
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Renal angiography followed by renal sympathetic denervation
Renal angiography alone
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resistant Hypertension focused on measuring Resistant hypertension, Renal denervation, Ambulatory blood pressure, Renal function, Simplicity catheter, Sham procedure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Erasme HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Renal angiography followed by renal sympathetic denervation

Renal angiography alone

Arm Description

Catheter based therapy for renal denervation using the Simplicity (TM) catheter (Ardian/Medtronic)

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.

Outcomes

Primary Outcome Measures

glomerular filtration rate
Isotopic and 24h urine sample measure of glomerular filtration rate.
Ambulatory systolic and diastolic blood pressure
Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device

Secondary Outcome Measures

Baroreflex sensitivity
Migroneugraphy recording of sympathetic nerve activity and testing of baroreflex sensitivity
Biological markers of acute kidney injury
Urine sample for NGAL, L-FABP and Cystatine C at baseline, H2, H6, 1, 3 and 6 months

Full Information

First Posted
January 25, 2012
Last Updated
January 27, 2012
Sponsor
Erasme University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01522430
Brief Title
Study of Catheter Based Renal Denervation Therapy in Hypertension
Acronym
DEPART
Official Title
DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasme University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: reduces daytime ambulatory blood pressure, improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistant Hypertension, Renal Denervation, Ambulatory Blood Pressure, Renal Function
Keywords
Resistant hypertension, Renal denervation, Ambulatory blood pressure, Renal function, Simplicity catheter, Sham procedure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal angiography followed by renal sympathetic denervation
Arm Type
Experimental
Arm Description
Catheter based therapy for renal denervation using the Simplicity (TM) catheter (Ardian/Medtronic)
Arm Title
Renal angiography alone
Arm Type
Sham Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Renal angiography followed by renal sympathetic denervation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Renal angiography alone
Intervention Description
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.
Primary Outcome Measure Information:
Title
glomerular filtration rate
Description
Isotopic and 24h urine sample measure of glomerular filtration rate.
Time Frame
6 month
Title
Ambulatory systolic and diastolic blood pressure
Description
Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Baroreflex sensitivity
Description
Migroneugraphy recording of sympathetic nerve activity and testing of baroreflex sensitivity
Time Frame
6 month
Title
Biological markers of acute kidney injury
Description
Urine sample for NGAL, L-FABP and Cystatine C at baseline, H2, H6, 1, 3 and 6 months
Time Frame
baseline, H2, H6, 1, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ARGACHA Jean francois, MD
Phone
33225555214
Email
Jean.Francois.Argacha@erasme.ulb.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François ARGACHA, MD
Organizational Affiliation
Erasme hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Francois ARGACHA, MD
Phone
3225555214
Email
Jean.Francois.Argacha@erasme.ulb.ac.be

12. IPD Sharing Statement

Learn more about this trial

Study of Catheter Based Renal Denervation Therapy in Hypertension

We'll reach out to this number within 24 hrs