HypertensionNCT02480517
Sham Controlled Study of Renal Denervation for Untreated Stage I and II Hypertension
A study testing Ultrasound in people with Hypertension, run by Kona Medical Inc..
Trial summary
The Wave VI study is a, multicenter, prospective, double-blind, randomized, sham controlled feasibility study of the safety of renal denervation in patients with stage I and II hypertension who have an average office systolic blood pressure between 150 and 180 mmHg and have not been on any antihypertensive medications… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2017
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age and no more than 80 years of age and can be safely removed from present antihypertensive therapy.
- Subject has not been taking any anti-hypertensive medications for at least 6 months prior to study enrollment.
- Subjects must have an average office seated systolic BP (SBP) between 150 mmHg and 180 mmHg inclusive in the untreated state for a minimum of 2 weeks.
- Mean daytime ambulatory SBP > 135 mmHg and no more than 170 mmHg in addition to mean daytime ambulatory DBP > 85 mmHg.
- Subject has two functioning kidneys.
- Subject has an eGFR value of ≥ 30 ml/min/1.73 m² (MDRD formula).
Who cannot join
- a.Any known secondary causes of hypertension.
- b.Evidence of current or past history of any clinically significant renal artery stenosis on duplex ultrasound as defined by a finding of at least one of the following:
- Peak systolic velocity (PSV) in the main renal artery of 150 cm/s or greater;
- Renal/aortic ratio (RAR) of greater than 3.5; or
- Complete lack of Doppler signal in any portion of the main renal artery (signifying complete occlusion).
- c.Previously documented finding of a 30% or greater renal artery stenosis in any renal arterial vessels as determined by angiographic examination, MRA or CTA.
Show all 19Show fewer
- d.Kidney stones that are 1 cm or greater in size, or that are symptomatic. e.History of intra-abdominal surgery within the past six months or surgery through retroperitoneal path at any time .
- f.Previous renal denervation g.Previous renal transplant. h.Heterogeneities in kidney morphology, such as large cysts or tumors (> 2 cm), which are determined at discretion of the investigator to potentially interfere with treatment.
- i.Hemodynamically unstable valvular heart disease for which BP reduction would be hazardous in the judgment of the site investigator-physician.
- j.Documented history of severe orthostatic hypotension that requires treatment or has necessitated hospitalization.
- k.Primary pulmonary hypertension l.History of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
- m.BMI over 35 kg/m² and/or mid-arm circumference > 45 cm (creates difficulty with ABPM measurements) n.Anatomy that precludes treatment as determined by the Surround Sound System. This may include any of the following:
- Target treatment depth as measured by the Surround Sound System of greater than 13 cm (Skin to target);
- Lack of visualization of the renal artery and or renal artery Doppler signal with the Surround Sound System;
- Lack of visualization of the renal parenchyma due to obscuration by bowel or other abdominal or retroperitoneal structures; or
- Narrow window between the superior margin of the iliac crest and the inferior margin of the lowest rib that prevents adequate positioning of both the Surround Sound imaging probe and the treatment unit.
- o.Subject is pregnant , nursing, or intends to become pregnant during the study period.
- p.Enrollment in another interventional research protocol. q.Any condition that, at the discretion of the investigator, would preclude participation in the study.
- r.Subject is unable, or unwilling, to comply with the protocol-required follow-up schedule.
Trial locations and contacts
No sites are listed yet.
Omar Dawood contact
About this study
Official title: Wave VI Feasibility Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Untreated Stage I and II Hypertension
The Wave VI study is a, multicenter, prospective, double-blind, randomized, sham controlled feasibility study of the safety of renal denervation in patients with stage I and II hypertension who have an average office systolic blood pressure between 150 and 180 mmHg and have not been on any antihypertensive medications for at least six months.
Read the detailed description
The primary objective of this feasibility study is to assess the safety of renal denervation using externally focused therapeutic ultrasound with non-invasive targeting for patients with stage I and II hypertension who are not on any antihypertensive medications. The key secondary objective is to assess the effect of the therapy on changes from baseline in ambulatory systolic BP.
- Conditions
- Hypertension
- Being tested
- Ultrasound, Sham Ultrasound
- Keywords
- Hypertension, Renal Denervation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Also called Surround Sound
Sham UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Investigational Therapy (Surround Sound) | Experimental | Investigational Therapy using external focused ultrasound Receives: Device: Ultrasound |
| Sham Control | Sham comparator | Blinded Sham Control Arm Receives: Device: Sham Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be assessed by incidence of Major Adverse Events (MAE), defined as a composite of the following events:
- All cause mortality;
- End-stage Renal Disease defined as eGFR < 15 ml/min or need for renal replacement therapy
- Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications as assessed by toxicological and other medical analyses and testing.
OR
- New renal artery stenosis > 70% confirmed by angiography within 3 months of randomization
Measured: 3 months follow-up
Change in Office Systolic Blood Pressure (OBP) as measured from screening visit one to the 3 months post randomization follow-up visit.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startSep 2016
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kona Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480517
- Sponsor's protocol ID
- KM14-003
- Status last verified
- Jan 2016
- First submitted
- 21 Jun 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wave VI Feasibility Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Untreated Stage I and II Hypertension
- ClinicalTrials.gov ID
- NCT02480517
- Acronym / sponsor ID
- KM14-003
- Conditions
- Hypertension
- Keywords
- Hypertension, Renal Denervation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kona Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Jun 2015 (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 Wave VI study is a, multicenter, prospective, double-blind, randomized, sham controlled feasibility study of the safety of renal denervation in patients with stage I and II hypertension who have an average office systolic blood pressure between 150 and 180 mmHg and have not been on any antihypertensive medications for at least six months.
Detailed description
The primary objective of this feasibility study is to assess the safety of renal denervation using externally focused therapeutic ultrasound with non-invasive targeting for patients with stage I and II hypertension who are not on any antihypertensive medications. The key secondary objective is to assess the effect of the therapy on changes from baseline in ambulatory systolic BP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Therapy (Surround Sound) | Experimental | Device: UltrasoundInvestigational Therapy using external focused ultrasound |
| Sham Control | Sham comparator | Device: Sham UltrasoundBlinded Sham Control Arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is at least 18 years of age and no more than 80 years of age and can be safely removed from present antihypertensive therapy.
- Subject has not been taking any anti-hypertensive medications for at least 6 months prior to study enrollment.
- Subjects must have an average office seated systolic BP (SBP) between 150 mmHg and 180 mmHg inclusive in the untreated state for a minimum of 2 weeks.
- Mean daytime ambulatory SBP > 135 mmHg and no more than 170 mmHg in addition to mean daytime ambulatory DBP > 85 mmHg.
- Subject has two functioning kidneys.
Key exclusion criteria (19 listed)
- a.Any known secondary causes of hypertension.
- b.Evidence of current or past history of any clinically significant renal artery stenosis on duplex ultrasound as defined by a finding of at least one of the following:
- Peak systolic velocity (PSV) in the main renal artery of 150 cm/s or greater;
- Renal/aortic ratio (RAR) of greater than 3.5; or
- Complete lack of Doppler signal in any portion of the main renal artery (signifying complete occlusion).
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 |
|---|---|---|
| UltrasoundAlso: Surround Sound | Device | Investigational Therapy (Surround Sound) |
| Sham Ultrasound | Device | Sham Control |
Primary outcome
Safety will be assessed by incidence of Major Adverse Events (MAE), defined as a composite of the following events:
Time frame: 3 months follow-up
* All cause mortality; * End-stage Renal Disease defined as eGFR < 15 ml/min or need for renal replacement therapy * Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications as assessed by toxicological and other medical analyses and testing. OR - New renal artery stenosis > 70% confirmed by angiography within 3 months of randomization
Change in Office Systolic Blood Pressure (OBP) as measured from screening visit one to the 3 months post randomization follow-up visit.
Time frame: Baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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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.
Omar Dawood contact
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Hypertension, run by Kona Medical Inc..
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 6 inclusion and 19 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 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Omar Dawood (odawood@konamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be assessed by incidence of Major Adverse Events (MAE), defined as a composite of the following events: (time frame: 3 months follow-up). The study lists 2 primary outcomes in all. 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 8 Jan 2016.