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

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ClinicalTrials.gov Identifier: NCT01865591
Recruitment Status : Unknown
Verified May 2013 by Sound Interventions, Inc..
Recruitment status was:  Recruiting
First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension Device: Ultrasound-based Renal Denervation Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial for the Assessment of Safety and Efficacy of the UltraSOUND Mediated InTerVentional Treatment of Resistant Hypertension
Study Start Date : April 2012
Estimated Primary Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Renal denervation
Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications.
Device: Ultrasound-based Renal Denervation
Other Name: Sound TX System




Primary Outcome Measures :
  1. Major adverse events [ Time Frame: 30 days ]
    All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure


Secondary Outcome Measures :
  1. Change from baseline in office blood pressure measurement [ Time Frame: 30 days, 3 months, 6 months, 9 months, 12 months ]
  2. Change from baseline in ambulatory 24-hour blood pressure measurement [ Time Frame: 6 months, 12 months ]
  3. Change from baseline in renal artery dimensions [ Time Frame: 30 days ]
    Change in renal artery dimensions as measured by renal angiography, CT, or MRI

  4. Change from baseline in creatinine [ Time Frame: 6 months ]
  5. Adverse events and device complications [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865591


Contacts
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Contact: David A. Smith dsmith@sounditv.com

Locations
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Czech Republic
Na Homolce Hospital Recruiting
Prague, Czech Republic
Contact: Liz Coling       liz.coling@homolka.cz   
Principal Investigator: Petr Neuzil, MD PhD FESC         
Sponsors and Collaborators
Sound Interventions, Inc.

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Responsible Party: Sound Interventions, Inc.
ClinicalTrials.gov Identifier: NCT01865591     History of Changes
Other Study ID Numbers: SITV-CL-0001
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013
Keywords provided by Sound Interventions, Inc.:
hypertension
uncontrolled hypertension
resistant hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases