Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension

Early Phase 1

• Conditions: Uncontrolled Hypertension
• Interventions: Device: Ultrasound-based Renal Denervation

• Registration Number: NCT01865591
• Lead Sponsor: Sound Interventions, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Status Verified: 2013-05
• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-05-30
• Last Update Submitted: 2013-05-30
• Study First Posted: 2013-05-31
• Last Update Posted: 2013-05-31
• Primary Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal denervation	Ultrasound-based Renal Denervation	Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications.

Primary Outcome Measures

Name	Time	Method
Major adverse events	30 days	All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure

Secondary Outcome Measures

Name	Time	Method
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	Change in renal artery dimensions as measured by renal angiography, CT, or MRI

Trial Locations

Locations (1)

Na Homolce Hospital; 🇨🇿 Prague, Czech Republic