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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 July 2016 |
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Main ID: |
NCT01628172 |
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Date of registration:
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12/06/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Renal Sympathetic Denervation for the Management of Chronic Hypertension
RELIEF |
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Scientific title:
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Renal Sympathetic Denervation for the Management of Chronic Hypertension |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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96 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01628172 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Czech Republic
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Contacts
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Name:
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Vivek Reddy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- = 18 and = 85 years of age
- Uncontrolled hypertension (defined as SBP = 140 mmHg during 24Hr Ambulatory BP
monitoring)
- Current treatment with = 3 anti-hypertensive drugs (including at least one diuretic)
- Accessibility of renal vasculature
- Ability to understand the requirements of the study
- Willingness to adhere to study restrictions and comply with all post-procedural
follow-up requirements
Exclusion Criteria:
- Secondary cause of hypertension
- White coat hypertension
- Estimated GFR < 45
- Type 1 Diabetes
- Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery
stenting or angioplasty)
- Life expectancy <1 year for any medical condition
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Uncontrolled Hypertension
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Intervention(s)
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Device: Biosense Webster Celcius Thermacool catheter
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Primary Outcome(s)
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Change in 24-hour ambulatory BP
[Time Frame: baseline and at 6 months]
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Secondary Outcome(s)
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change in office BP
[Time Frame: baseline, 6 months, and 12 months]
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Creatinine
[Time Frame: baseline and at 6 months]
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Renal artery dimensions
[Time Frame: baseline and at 6 months]
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change in ambulatory BP
[Time Frame: baseline and at 12 months]
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Secondary ID(s)
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GCO 11-0965
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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