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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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19 February 2015 |
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Main ID: |
NCT01865591 |
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Date of registration:
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23/05/2013 |
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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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Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension
SoundITV |
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Scientific title:
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A Clinical Trial for the Assessment of Safety and Efficacy of the UltraSOUND Mediated InTerVentional Treatment of Resistant Hypertension |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01865591 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 0
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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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Liz Coling |
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Address:
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Telephone:
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Email:
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liz.coling@homolka.cz |
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Affiliation:
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Name:
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David A. Smith |
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Address:
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Telephone:
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Email:
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dsmith@sounditv.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Uncontrolled hypertension (defined as SBP = 140 mmHg during 24Hr Ambulatory BP
monitoring)
- Current treatment with = 3 anti-hypertensive drugs (including at least one diuretic)
- Renal artery diameter =5mm by digital angiography
- Accessibility of renal vasculature
Exclusion Criteria:
- Estimated GFR < 45
- Type 1 Diabetes
- Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery
stenting or angioplasty)
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: Ultrasound-based Renal Denervation
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Primary Outcome(s)
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Major adverse events
[Time Frame: 30 days]
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Secondary Outcome(s)
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Change from baseline in ambulatory 24-hour blood pressure measurement
[Time Frame: 6 months, 12 months]
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Change from baseline in office blood pressure measurement
[Time Frame: 30 days, 3 months, 6 months, 9 months, 12 months]
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Adverse events and device complications
[Time Frame: 12 months]
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Change from baseline in renal artery dimensions
[Time Frame: 30 days]
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Change from baseline in creatinine
[Time Frame: 6 months]
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Secondary ID(s)
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SITV-CL-0001
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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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