A Clinical Trial for the Assessment of Safety and Efficacy of the UltraSOUND Mediated InTerVentional Treatment of Resistant Hypertension

Sound Interventions, Inc.1 site in 1 country30 target enrollmentApril 2012

ConditionsUncontrolled Hypertension

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Uncontrolled Hypertension
Sponsor: Sound Interventions, Inc.
Enrollment: 30
Locations: 1
Primary Endpoint: Major adverse events
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

July 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sound Interventions, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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)

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)