Study of Catheter Based Renal Denervation Therapy in Hypertension
NCT ID: NCT01522430
Last Updated: 2012-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2012-01-31
2016-12-31
Brief Summary
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1. reduces daytime ambulatory blood pressure,
2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Renal angiography followed by renal sympathetic denervation
Catheter based therapy for renal denervation using the Simplicity (TM) catheter (Ardian/Medtronic)
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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 known renal atherosclerotic lesions,
* previous procedures in the renal arteries,
* known unsuitable anatomy for the procedure,
* previous nephrectomy,
* contrast agent allergy,
* hyperthyroidia.
18 Years
85 Years
ALL
No
Sponsors
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Erasme University Hospital
OTHER
Responsible Party
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Jean Francois Argacha
Principal Investigator
Principal Investigators
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Jean-François ARGACHA, MD
Role: PRINCIPAL_INVESTIGATOR
Erasme hospital
Locations
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Erasme Hospital
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Jean Francois ARGACHA, MD
Role: primary
Other Identifiers
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140576
Identifier Type: -
Identifier Source: org_study_id