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Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension (SoundITV)

Primary Purpose

Uncontrolled Hypertension

Status
Unknown status
Phase
Early Phase 1
Locations
Czech Republic
Study Type
Interventional
Intervention
Ultrasound-based Renal Denervation
Sponsored by
Sound Interventions, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncontrolled Hypertension focused on measuring hypertension, uncontrolled hypertension, resistant hypertension

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Na Homolce HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal denervation

Arm Description

Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications.

Outcomes

Primary Outcome Measures

Major adverse events
All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure

Secondary Outcome Measures

Change from baseline in office blood pressure measurement
Change from baseline in ambulatory 24-hour blood pressure measurement
Change from baseline in renal artery dimensions
Change in renal artery dimensions as measured by renal angiography, CT, or MRI
Change from baseline in creatinine
Adverse events and device complications

Full Information

First Posted
May 23, 2013
Last Updated
May 30, 2013
Sponsor
Sound Interventions, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01865591
Brief Title
Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension
Acronym
SoundITV
Official Title
A Clinical Trial for the Assessment of Safety and Efficacy of the UltraSOUND Mediated InTerVentional Treatment of Resistant Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sound Interventions, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Hypertension
Keywords
hypertension, uncontrolled hypertension, resistant hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal denervation
Arm Type
Experimental
Arm Description
Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications.
Intervention Type
Device
Intervention Name(s)
Ultrasound-based Renal Denervation
Other Intervention Name(s)
Sound TX System
Primary Outcome Measure Information:
Title
Major adverse events
Description
All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change from baseline in office blood pressure measurement
Time Frame
30 days, 3 months, 6 months, 9 months, 12 months
Title
Change from baseline in ambulatory 24-hour blood pressure measurement
Time Frame
6 months, 12 months
Title
Change from baseline in renal artery dimensions
Description
Change in renal artery dimensions as measured by renal angiography, CT, or MRI
Time Frame
30 days
Title
Change from baseline in creatinine
Time Frame
6 months
Title
Adverse events and device complications
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David A. Smith
Email
dsmith@sounditv.com
Facility Information:
Facility Name
Na Homolce Hospital
City
Prague
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liz Coling
Email
liz.coling@homolka.cz
First Name & Middle Initial & Last Name & Degree
Petr Neuzil, MD PhD FESC

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension

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