Study of Catheter Based Renal Denervation Therapy in Hypertension

Resistant Hypertension Clinical Trial

— DEPART  

Official title:

DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01522430
• Other study ID #: 140576
• Status: Recruiting
• Phase: Phase 3
• First received: January 25, 2012
• Last updated: January 27, 2012
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2012
• Source: Erasme University Hospital
• Contact: ARGACHA Jean francois, MD
• Phone: 33225555214
• Email: Jean.Francois.Argacha[@]erasme.ulb.ac.be
• Is FDA regulated: No
• Health authority: Belgium: N°agreation by "Ordre des Médecins": OM021
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ambulatory Blood Pressure
• Hypertension
• Renal Denervation
• Renal Function
• Resistant Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glomerular filtration rate	Isotopic and 24h urine sample measure of glomerular filtration rate.	6 month	Yes
Primary	Ambulatory systolic and diastolic blood pressure	Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device	6 month	No
Secondary	Baroreflex sensitivity	Migroneugraphy recording of sympathetic nerve activity and testing of baroreflex sensitivity	6 month	No
Secondary	Biological markers of acute kidney injury	Urine sample for NGAL, L-FABP and Cystatine C at baseline, H2, H6, 1, 3 and 6 months	baseline, H2, H6, 1, 3 and 6 months	Yes