Status:
UNKNOWN
Study of Catheter Based Renal Denervation Therapy in Hypertension
Lead Sponsor:
Erasme University Hospital
Conditions:
Resistant Hypertension
Renal Denervation
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01522430
Start Date
January 1 2012
End Date
December 1 2016
Last Update
January 31 2012
Active Locations (1)
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1
Erasme Hospital
Brussels, Belgium, 1070