Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension

Uncontrolled Hypertension Clinical Trial

— SoundITV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01865591
• Other study ID #: SITV-CL-0001
• Status: Recruiting
• Phase: Phase 0
• First received: May 23, 2013
• Last updated: May 30, 2013
• Start date: April 2012

Study information

• Verified date: May 2013
• Source: Sound Interventions, Inc.
• Contact: David A. Smith
• Email: dsmith[@]sounditv.com
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

Device:
• Ultrasound-based Renal Denervation

Locations

Country	Name	City	State
Czech Republic	Na Homolce Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Sound Interventions, Inc.

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse events	All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure	30 days	Yes
Secondary	Change from baseline in office blood pressure measurement		30 days, 3 months, 6 months, 9 months, 12 months	No
Secondary	Change from baseline in ambulatory 24-hour blood pressure measurement		6 months, 12 months	No
Secondary	Change from baseline in renal artery dimensions	Change in renal artery dimensions as measured by renal angiography, CT, or MRI	30 days	Yes
Secondary	Change from baseline in creatinine		6 months	Yes
Secondary	Adverse events and device complications		12 months	Yes