HypertensionPhase 1NCT01638195
A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension
A Phase 1 study testing Focused Ultrasound in people with Hypertension, run by Kona Medical Inc. at 1 site in Australia.
Trial summary
This study is a prospective, single-institution trial wherein twenty subjects with refractory hypertension will receive the experimental focused ultrasound renal denervation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2012to Sep 2014
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age.
- Subject has systolic blood pressure of 160 mmHg or greater.
- Subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
- Subject has two functioning kidneys, defined as eGFR ≥ 60 ml/min.
Who cannot join
- Subject has history of nephrectomy, kidney tumor or hydronephrosis.
- Subject has renal stenosis greater than 50%.
- Subject has presence of accessory renal artery with lumen ≥ 3 mm.
- Subject has a renal stent.
- Subject has end stage renal disease requiring dialysis or renal implant.
- Subject has Serum Cr > 3.0 mg/dL or equivalent calculated Glomerular Filtration Rate (GFR).
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- Subject has a history of kidney stones.
- Subject has a history of abdominal surgery.
- Subject has a history of heterogeneities in the kidney such as cysts or tumors.
- Subject has a history of pyelonephritis.
- Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
- Subject has hemodynamically significant valvular heart disease.
- Subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI.
- Subject has a body weight > 150 kilograms.
- Subject has a target treatment depth > 14 cm.
- Subject is pregnant, nursing or intends to become pregnant during the trial period.
- Subject is currently enrolled in other potentially confounding research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study: A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension
This study is a prospective, single-institution trial wherein twenty subjects with refractory hypertension will receive the experimental focused ultrasound renal denervation therapy. Safety will be assessed by incidence and evaluation of serious adverse effects associated with the investigational procedure through 52-week evaluation of bilateral treatment. Clinical utility will also be evaluated by comparison pre and post therapy systolic and diastolic blood pressure and norepinephrine spillover.
Read the detailed description
This study is a prospective, single-institution trial wherein each included subject will receive the experimental focused ultrasound renal denervation therapy. It will be conducted on a maximum of twenty adult male or female patients who meet the inclusion and exclusion criteria and have signed the informed consent form.
Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Clinical utility is the secondary endpoint of this study. Clinical utility will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure and norepinephrine (NE) spillover.
The study has been designed so that subjects are treated in a careful and stepwise fashion in order to minimize the potential risks associated with the investigational therapy. After completing baseline testing, the investigational focused ultrasound therapy will be unilaterally administered. Each subject is first treated on the right side. Renal angiograms are obtained after treatment is completed to ensure any resulting complications are quickly identified. After three weeks of treatment, the subject is further evaluated again with blood tests, EKG, angiogram and a norepinephrine spillover test. If any complications that preclude participation in the study are revealed, then additional treatment is halted. Upon safe treatment of the right renal artery, the left renal artery is then treated. Safety and functional evaluation occurs three weeks, and three and six months after completion of the last treatment. This sequential unilateral treatment scheme minimizes the potential risks to any given subject.
The second key factor in designing this study is the stepwise progression of applying the investigational therapy dose. Low dosing levels with established safety profile will first be applied before administering higher dosing levels. The low dosing level will be administered to the first ten subjects. The specified low dosing level was selected because it is just above the threshold value where renal denervation was detectable in the swine model, and patients participating in this cohort are expected to benefit from modest levels of renal neurolysis as measured by the norepinephrine spillover test. Only after five of the first ten subjects have been safely treated and evaluated at the 3-week follow-up evaluation may the remaining ten subjects (i.e., subjects #11 - 20) be treated with the higher dosing treatment. The specified higher dosing level was selected to induce increased renal neurolysis and thereby enable the expected escalated-dose response to be measured.
- Conditions
- Hypertension
- Being tested
- Focused Ultrasound
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused UltrasoundDevice
Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Externally Focused Ultrasound | Experimental | Not described Receives: Device: Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Included in this assessment will be the proportion of subjects with any of the following outcomes: (1) death, or (2) medical morbidity, including but not limited to renal artery aneurysm, stenosis, significant deterioration of renal function, fistulae or urethral stenosis.
Measured: 52 weeks post-treatment
Secondary outcomes (1)
Blood Pressure Reduction
Measured: 52 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kona Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Whitbourn, M.D., Principal investigator, St Vincent's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638195
- Sponsor's protocol ID
- KM11-002
- Status last verified
- Apr 2015
- First submitted
- 8 Jul 2012
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study: A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension
- ClinicalTrials.gov ID
- NCT01638195
- Acronym / sponsor ID
- KM11-002
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kona Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Jul 2012 (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.
This study is a prospective, single-institution trial wherein twenty subjects with refractory hypertension will receive the experimental focused ultrasound renal denervation therapy. Safety will be assessed by incidence and evaluation of serious adverse effects associated with the investigational procedure through 52-week evaluation of bilateral treatment. Clinical utility will also be evaluated by comparison pre and post therapy systolic and diastolic blood pressure and norepinephrine spillover.
Detailed description
This study is a prospective, single-institution trial wherein each included subject will receive the experimental focused ultrasound renal denervation therapy. It will be conducted on a maximum of twenty adult male or female patients who meet the inclusion and exclusion criteria and have signed the informed consent form.
Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Clinical utility is the secondary endpoint of this study. Clinical utility will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure and norepinephrine (NE) spillover.
The study has been designed so that subjects are treated in a careful and stepwise fashion in order to minimize the potential risks associated with the investigational therapy. After completing baseline testing, the investigational focused ultrasound therapy will be unilaterally administered. Each subject is first treated on the right side. Renal angiograms are obtained after treatment is completed to ensure any resulting complications are quickly identified. After three weeks of treatment, the subject is further evaluated again with blood tests, EKG, angiogram and a norepinephrine spillover test. If any complications that preclude participation in the study are revealed, then additional treatment is halted. Upon safe treatment of the right renal artery, the left renal artery is then treated. Safety and functional evaluation occurs three weeks, and three and six months after completion of the last treatment. This sequential unilateral treatment scheme minimizes the potential risks to any given subject.
The second key factor in designing this study is the stepwise progression of applying the investigational therapy dose. Low dosing levels with established safety profile will first be applied before administering higher dosing levels. The low dosing level will be administered to the first ten subjects. The specified low dosing level was selected because it is just above the threshold value where renal denervation was detectable in the swine model, and patients participating in this cohort are expected to benefit from modest levels of renal neurolysis as measured by the norepinephrine spillover test. Only after five of the first ten subjects have been safely treated and evaluated at the 3-week follow-up evaluation may the remaining ten subjects (i.e., subjects #11 - 20) be treated with the higher dosing treatment. The specified higher dosing level was selected to induce increased renal neurolysis and thereby enable the expected escalated-dose response to be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Externally Focused Ultrasound | Experimental | Device: Focused Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is at least 18 years of age.
- Subject has systolic blood pressure of 160 mmHg or greater.
- Subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
- Subject has two functioning kidneys, defined as eGFR ≥ 60 ml/min.
Key exclusion criteria (17 listed)
- Subject has history of nephrectomy, kidney tumor or hydronephrosis.
- Subject has renal stenosis greater than 50%.
- Subject has presence of accessory renal artery with lumen ≥ 3 mm.
- Subject has a renal stent.
- Subject has end stage renal disease requiring dialysis or renal implant.
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 |
|---|---|---|
| Focused UltrasoundFocused Ultrasound | Device | Externally Focused Ultrasound |
Primary outcome
Safety
Time frame: 52 weeks post-treatment
Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Included in this assessment will be the proportion of subjects with any of the following outcomes: (1) death, or (2) medical morbidity, including but not limited to renal artery aneurysm, stenosis, significant deterioration of renal function, fistulae or urethral stenosis.
1 secondary outcome
Blood Pressure Reduction
Time frame: 52 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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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.
Robert Whitbourn, M.D. principal investigator
St Vincent's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Focused Ultrasound in people with Hypertension, run by Kona Medical Inc. at 1 site in Australia.
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 17 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: finished, as of the sponsor's last update on 13 Apr 2015. 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 Australia. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 52 weeks post-treatment). 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 13 Apr 2015.