Ambulatory Blood Pressure, Renal Denervation, Renal Function, Resistant Hypertension
Conditions
Keywords
Resistant hypertension, Renal denervation, Ambulatory blood pressure, Renal function, Simplicity catheter, Sham procedure
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.
Interventions
PROCEDURERenal 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.
PROCEDURERenal 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.
Sponsors
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glomerular filtration rate | 6 month | Isotopic and 24h urine sample measure of glomerular filtration rate. |
| Ambulatory systolic and diastolic blood pressure | 6 month | Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baroreflex sensitivity | 6 month | Migroneugraphy recording of sympathetic nerve activity and testing of baroreflex sensitivity |
| Biological markers of acute kidney injury | 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 |
Countries
Belgium
Contacts
Primary ContactARGACHA Jean francois, MD
Outcome results
None listed