Status:
UNKNOWN
Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension
Lead Sponsor:
Sound Interventions, Inc.
Conditions:
Uncontrolled Hypertension
Eligibility:
All Genders
18-85 years
Phase:
EARLY_PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- Estimated GFR \< 45
- Type 1 Diabetes
- Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01865591
Start Date
April 1 2012
Last Update
May 31 2013
Active Locations (1)
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1
Na Homolce Hospital
Prague, Czechia