Uncontrolled HypertensionEarly Phase 1SoundITVNCT01865591
Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension
A Early Phase 1 study testing Ultrasound-based Renal Denervation in people with Uncontrolled Hypertension, run by Sound Interventions, Inc. at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Ultrasound-based Renal Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- Apr 2012to Jul 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Estimated GFR < 45
- Type 1 Diabetes
- Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
Trial locations and contacts
1 site in 1 country.
David A. Smith contact
Czechia1 site, 1 recruiting
- Recruiting
Na Homolce Hospital
Prague
Liz Coling, liz.coling@homolka.cz
Petr Neuzil, MD PhD FESC
About this study
Official title: A Clinical Trial for the Assessment of Safety and Efficacy of the UltraSOUND Mediated InTerVentional Treatment of Resistant Hypertension
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.
- Conditions
- Uncontrolled Hypertension
- Being tested
- Ultrasound-based Renal Denervation
- Keywords
- hypertension, uncontrolled hypertension, resistant hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-based Renal DenervationDevice
Also called Sound TX System
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Experimental | Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications. Receives: Device: Ultrasound-based Renal Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse events
All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure
Measured: 30 days
Secondary outcomes (5)
Change from baseline in office blood pressure measurement
Measured: 30 days, 3 months, 6 months, 9 months, 12 months
Change from baseline in ambulatory 24-hour blood pressure measurement
Measured: 6 months, 12 months
Change from baseline in renal artery dimensions
Change in renal artery dimensions as measured by renal angiography, CT, or MRI
Measured: 30 days
Change from baseline in creatinine
Measured: 6 months
Adverse events and device complications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startApr 2012
- Primary completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sound Interventions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865591
- Sponsor's protocol ID
- SITV-CL-0001
- Acronym
- SoundITV
- Status last verified
- May 2013
- First submitted
- 23 May 2013
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial for the Assessment of Safety and Efficacy of the UltraSOUND Mediated InTerVentional Treatment of Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01865591
- Acronym / sponsor ID
- SoundITV / SITV-CL-0001
- Conditions
- Uncontrolled Hypertension
- Keywords
- hypertension, uncontrolled hypertension, resistant hypertension
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sound Interventions, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (estimated)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Device: Ultrasound-based Renal DenervationSubjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Estimated GFR < 45
- Type 1 Diabetes
- Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-based Renal DenervationAlso: Sound TX System | Device | Renal denervation |
Primary outcome
Major adverse events
Time frame: 30 days
All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure
5 secondary outcomes
Change from baseline in office blood pressure measurement
Time frame: 30 days, 3 months, 6 months, 9 months, 12 months
Change from baseline in ambulatory 24-hour blood pressure measurement
Time frame: 6 months, 12 months
Change from baseline in renal artery dimensions
Time frame: 30 days
Change from baseline in creatinine
Time frame: 6 months
Adverse events and device complications
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Smith contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ultrasound-based Renal Denervation in people with Uncontrolled Hypertension, run by Sound Interventions, Inc. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David A. Smith (dsmith@sounditv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.