Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension

NCT ID: NCT01865591

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Brief Summary

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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

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Conditions

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Uncontrolled Hypertension

Keywords

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hypertension uncontrolled hypertension resistant hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal denervation

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

Group Type EXPERIMENTAL

Ultrasound-based Renal Denervation

Intervention Type DEVICE

Interventions

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Ultrasound-based Renal Denervation

Intervention Type DEVICE

Other Intervention Names

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Sound TX System

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sound Interventions, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Na Homolce Hospital

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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David A. Smith

Role: CONTACT

Email: [email protected]

Facility Contacts

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Liz Coling

Role: primary

Other Identifiers

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SITV-CL-0001

Identifier Type: -

Identifier Source: org_study_id