NCT01865591UnknownEarly Phase 1
A Clinical Trial for the Assessment of Safety and Efficacy of the UltraSOUND Mediated InTerVentional Treatment of Resistant Hypertension
Sound Interventions, Inc.2 sites in 2 countries30 target enrollmentStarted: April 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Early Phase 1
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Major adverse events
Study Overview
Brief Summary
The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Renal denervation
Experimental
Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications.
Intervention: Ultrasound-based Renal Denervation (Device)
Outcomes
Primary Outcomes
Major adverse events
Time Frame: 30 days
All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure
Secondary Outcomes
- Adverse events and device complications(12 months)
- Change from baseline in creatinine(6 months)
- Change from baseline in office blood pressure measurement(30 days, 3 months, 6 months, 9 months, 12 months)
- Change from baseline in ambulatory 24-hour blood pressure measurement(6 months, 12 months)
- Change from baseline in renal artery dimensions(30 days)
Investigators
Study Sites (2)
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