HypertensionWAVE_IVNCT02029885
Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension
A study testing Investigational Therapy (Surround Sound) in people with Hypertension, run by Kona Medical Inc. at 28 sites in 8 countries.
Trial summary
To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Investigational Therapy (Surround Sound)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 28 sitesin 8 countries
- Study dates
- Aug 2014to Mar 2018
- 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 90 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 90 years of age
- Average SBP ≥ 160 mmHg
- 24 hour average ABPM daytime SBP ≥ 135 mmHg.
- No medication changes for a minimum of 1 months prior to screening.
- At minimum, subject must be on at least three antihypertensive medications, with one being a diuretic, and each must meet one or more of the following full dose criteria:
- Highest labeled dose according to medication's labeling;
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- Highest usual dose per clinical guidelines JNC-7;
- Highest tolerated dose; and/or
- Highest appropriate dose for the subject per the PI's clinical judgment.
- Subject has two functioning kidneys.
- Subject has an eGFR value of ≥ 30 ml/min/1.73 m² (MDRD formula).
Who cannot join
- Subject has any secondary cause of hypertension
- Subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and Doppler analysis on ultrasound
- Subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment
- Subject has a history of intra-abdominal surgery within the past six months
- Subject has heterogeneities in the kidney such as large cysts or tumors that are determined at discretion of the investigator to potentially interfere with treatment.
- Stenotic valvular heart disease for which BP reduction would be hazardous as determined by referring physician.
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- MI, unstable angina, or CVA in the prior 6 months.
- Known severe primary pulmonary HTN
- 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 BMI over 40 km/m^2
- Subject has a target treatment depth over 13 cm.
- Subject has anatomy that precludes treatment with the Kona Medical Surround Sound System.
- Subject is pregnant, nursing, or intends to become pregnant during the trial period.
- Subject is currently enrolled in other potentially confounding research.
- Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
- Subject is unable, or unwilling, to comply with the protocol-required follow-up schedule
Trial locations and contacts
28 sites in 8 countries.
Omar Dawood contact
28 sites in 8 countries
Germany9 sites, 9 recruiting
- Recruiting
University Hospital Bonn
Bonn
Georg Nickenig, MD
- Recruiting
Uniklinik Köln
Cologne
Tatjana Schewior, +49 (221) 478 88273, tatjana.schewior@uk-koeln.de
Hannes Reuter
- Recruiting
University Hospital of the University of Erlangen-Nuremberg
Erlangen
Sabine Thuemmler, sabine.thuemmler@uk-erlangen.de
Roland Schmieder, MD
- Recruiting
CardioVascular Center Frankfurt - Sankt Katharinen Hospital
Frankfurt
Horst Sievert, MD
- Recruiting
University Hospital Hamburg-Eppendorf
Hamburg
Ulrich Wenzel Oberarzt, MD, +49(40) 7410-50026, wenzel@uke.de
Ulrich Wenzel Oberarzt, MD
- Recruiting
Universitaetsklinikum Leipzig
Leipzig
Ursula Banning-Eichenseer, +49 341 9720657, ursula.banning-eichenseer@med.uni-leipzig.de
Dierk Scheinert, MD
- Recruiting
Sana CardioMed Nord
Lübeck
Anke Constantz, +49 451 585 1951, anke.constantz@sana.de
Joachim Weil, MD
- Recruiting
Deutsches Herzzentrum Muenchen
Munich
Ilka Ott, MD, +49 (89) 1218-4578, ott@dhm.mhn.de
Ilka Ott, MD
- Recruiting
Clemens Hospital GmbH
Münster
Peter Baumgart, MD
United Kingdom7 sites, 6 recruiting
- Recruiting
Birmingham Heartlands Hospital
Birmingham
Indranil Desgupta, MD, DM, FRCP
- Recruiting
University Hospital Wales
Cardiff
James Coulson, MD, +44 (0) 7968 366691, coulsonjm@cardiff.ac.uk
James Coulson, MD
- Recruiting
Royal Devon and Exeter Hospital
Exeter
Andrew Sharp, MD, andrew.sharp5@nhs.net
Andrew Sharp, MD
- Recruiting
University of Glasgow
Glasgow
Alan Jardine
- Recruiting
St. Bartholomew's Hospital
London
Mel Lobo, PhD, +44 (0) 7780 700440, m.d.lobo@qmul.ac.uk
Mel Lobo, MD, PhD
- Withdrawn
University College London
London
- Recruiting
Southampton University Hospital
Southampton
James Wilkinson, +44 (0) 7931 703058, james.wilkinson@uhs.nhs.uk
James Wilkinson, PhD FRCP
Czechia5 sites
- Active, not recruiting
St. Anne's University Hospital
Brno
- Active, not recruiting
University Hospital Brno
Brno
- Active, not recruiting
Městská Nomocnice Ostrava
Ostrava
- Withdrawn
General University Hospital
Prague
- Active, not recruiting
Nemocnice Na Homolee Hospital
Prague
Colombia2 sites
- Terminated
Angiografia de Occidente, S.A.
Cali
- Terminated
CHD Cardio Centro de Excelencia SAS
Cali
Poland2 sites, 2 recruiting
- Recruiting
Oddział Kliniczny II Kliniki Kardiologii
Krakow
Dariusz Dudek, MD, +48 12 42 47 181, mcdudek@cyfronet.pl
Dariusz Dudek, MD, PhD
- Recruiting
Institute Of Cardiology
Warsaw
Adam Witkowski, MD, +48 22 34 34 127, witkowski@hbz.pl
Adam Witkowski, MD, PhD
Austria1 site, 1 recruiting
- Recruiting
Medizinischen Universität Wien -UK für Klinische Pharmakologie
Vienna
Michael Wolzt, MD
About this study
Official title: Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension
To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.
Read the detailed description
This study is a sham controlled, double blind study of subjects with uncontrolled hypertension consisting of two arms, sham and therapy. Bilateral renal denervation will be performed non-invasively using the Kona Medical Surround Sound System which delivers focused ultrasound therapy to ablate the nerves surrounding the renal artery utilizing real time ultrasound for targeting and tracking.
- Conditions
- Hypertension
- Being tested
- Investigational Therapy (Surround Sound), Sham Control
- 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.
Investigational Therapy (Surround Sound)Device
Sham ControlDevice
| Study group | Role | What they receive |
|---|---|---|
| Investigational Therapy (Surround Sound) | Experimental | Investigational Therapy using external focused ultrasound Receives: Device: Investigational Therapy (Surround Sound) |
| Sham Control | Sham comparator | Blinded Sham Control Arm Receives: Device: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety at 6 weeks follow-up
Safety will be assessed by incidence of Major Adverse Events (MAE), defined as a composite of the following events at 6-weeks 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 6 months of randomization
Measured: 6 weeks
Change in OBP
Change in Office Systolic Blood Pressure (OBP) as measured from screening visit one to the 6 month post randomization follow-up visit.
Measured: 6 months
Secondary outcomes (1)
Change in ABPM
Change in average 24-hour ambulatory blood pressure from screening to the 6 month follow-up visit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kona Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roland Schmieder, MD, Principal investigator, University Hospital of University of Erlangen-Nuremberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029885
- Sponsor's protocol ID
- KM14-001
- Acronym
- WAVE_IV
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2014
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saxena M, Shour T, Shah M, Wolff CB, Julu POO, Kapil V, Collier DJ, Ng FL, Gupta A, Balawon A, Pheby J, Zak A, Rull G, O'Brien B, Schmieder RE, Lobo MD. Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success. J Am Heart Assoc. 2018 Jun 12;7(12):e009151. doi: 10.1161/JAHA.118.009151.
PubMed 29895590
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 IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT02029885
- Acronym / sponsor ID
- WAVE_IV / KM14-001
- Conditions
- Hypertension
- Keywords
- Hypertension, Renal Denervation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Kona Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 8 Jan 2014 (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.
To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.
Detailed description
This study is a sham controlled, double blind study of subjects with uncontrolled hypertension consisting of two arms, sham and therapy. Bilateral renal denervation will be performed non-invasively using the Kona Medical Surround Sound System which delivers focused ultrasound therapy to ablate the nerves surrounding the renal artery utilizing real time ultrasound for targeting and tracking.
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: Investigational Therapy (Surround Sound)Investigational Therapy using external focused ultrasound |
| Sham Control | Sham comparator | Device: Sham ControlBlinded Sham Control Arm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is at least 18 years of age and no more than 90 years of age
- Average SBP ≥ 160 mmHg
- 24 hour average ABPM daytime SBP ≥ 135 mmHg.
- No medication changes for a minimum of 1 months prior to screening.
- At minimum, subject must be on at least three antihypertensive medications, with one being a diuretic, and each must meet one or more of the following full dose criteria:
Key exclusion criteria (17 listed)
- Subject has any secondary cause of hypertension
- Subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and Doppler analysis on ultrasound
- Subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment
- Subject has a history of intra-abdominal surgery within the past six months
- Subject has heterogeneities in the kidney such as large cysts or tumors that are determined at discretion of the investigator to potentially interfere with treatment.
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 |
|---|---|---|
| Investigational Therapy (Surround Sound) | Device | Investigational Therapy (Surround Sound) |
| Sham Control | Device | Sham Control |
Primary outcome
Safety at 6 weeks follow-up
Time frame: 6 weeks
Safety will be assessed by incidence of Major Adverse Events (MAE), defined as a composite of the following events at 6-weeks 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 6 months of randomization
Change in OBP
Time frame: 6 months
Change in Office Systolic Blood Pressure (OBP) as measured from screening visit one to the 6 month post randomization follow-up visit.
1 secondary outcome
Change in ABPM
Time frame: 6 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.
- Derived from this study: PubMed 29895590Saxena M, Shour T, Shah M, Wolff CB, Julu POO, Kapil V, Collier DJ, Ng FL, Gupta A, Balawon A, Pheby J, Zak A, Rull G, O'Brien B, Schmieder RE, Lobo MD. Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success. J Am Heart Assoc. 2018 Jun 12;7(12):e009151. doi: 10.1161/JAHA.118.009151.
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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
Roland Schmieder, MD principal investigator
University Hospital of University of Erlangen-Nuremberg
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Therapy (Surround Sound) in people with Hypertension, run by Kona Medical Inc. at 28 sites in 8 countries.
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 11 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: 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.
Where is the study taking place?
The record lists 28 sites in Germany, United Kingdom, Czechia, Colombia, Poland and 3 more countries. 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. 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 at 6 weeks follow-up (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT02029885, which also lists 1 linked publication.
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.