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Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension (WAVE_IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02029885
Recruitment Status : Unknown
Verified January 2016 by Kona Medical Inc..
Recruitment status was:  Recruiting
First Posted : January 8, 2014
Last Update Posted : January 8, 2016
Information provided by (Responsible Party):
Kona Medical Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Device: Investigational Therapy (Surround Sound) Device: Sham Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension
Study Start Date : August 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Investigational Therapy (Surround Sound)
Investigational Therapy using external focused ultrasound
Device: Investigational Therapy (Surround Sound)
Sham Comparator: Sham Control
Blinded Sham Control Arm
Device: Sham Control

Primary Outcome Measures :
  1. 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.


    - New renal artery stenosis > 70% confirmed by angiography within 6 months of randomization

  2. 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.

Secondary Outcome Measures :
  1. Change in ABPM [ Time Frame: 6 months ]
    Change in average 24-hour ambulatory blood pressure from screening to the 6 month follow-up visit

Other Outcome Measures:
  1. Chronic Safety [ Time Frame: 6 months ]

    Chronic safety is assessed and compared between the control and treatment groups at 6 months post-randomization as follows:

    • Cardiovascular/Renal Death;
    • End stage Renal Disease
    • Increase in serum creatinine of > 50%; and
    • Hospitalization for hypertensive crisis not confirmed non-adherence with medications.

  2. Reduction in blood pressure [ Time Frame: 6 months ]
    Reduction in systolic and diastolic blood pressure as compared between groups at time points through the 6 month follow-up period for interval differences of 10,15 and 20 mmHg.

  3. Incidence of achieving target OBP [ Time Frame: 6 months ]
    Incidence of achieving target OBP (< 140 mmHg) through the 6 month follow-up period.

  4. Reduction in anti-hypertensive medications [ Time Frame: 6 months ]
    Incidence of reductions in the number of anti-hypertensive medications and reductions in the doses of anti-hypertensive medications.

  5. Changes in OBP [ Time Frame: 24 months ]
    Changes in OBP from screening to the 12, 18, and 24 month follow-up periods.

  6. Changes in HR [ Time Frame: 6 months ]
    Changes in HR (as measured by OBP and ABPM) through the 6 month follow-up period.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject is at least 18 years of age and no more than 90 years of age
  2. Average SBP ≥ 160 mmHg
  3. 24 hour average ABPM daytime SBP ≥ 135 mmHg.
  4. No medication changes for a minimum of 1 months prior to screening.
  5. 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:

    1. Highest labeled dose according to medication's labeling;
    2. Highest usual dose per clinical guidelines JNC-7;
    3. Highest tolerated dose; and/or
    4. Highest appropriate dose for the subject per the PI's clinical judgment.
  6. Subject has two functioning kidneys.
  7. Subject has an eGFR value of ≥ 30 ml/min/1.73 m² (MDRD formula).

Exclusion Criteria:

  1. Subject has any secondary cause of hypertension
  2. Subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and Doppler analysis on ultrasound
  3. Subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment
  4. Subject has a history of intra-abdominal surgery within the past six months
  5. 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.
  6. Stenotic valvular heart disease for which BP reduction would be hazardous as determined by referring physician.
  7. MI, unstable angina, or CVA in the prior 6 months.
  8. Known severe primary pulmonary HTN
  9. Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
  10. Subject has hemodynamically significant valvular heart disease.
  11. Subject has BMI over 40 km/m^2
  12. Subject has a target treatment depth over 13 cm.
  13. Subject has anatomy that precludes treatment with the Kona Medical Surround Sound System.
  14. Subject is pregnant, nursing, or intends to become pregnant during the trial period.
  15. Subject is currently enrolled in other potentially confounding research.
  16. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
  17. Subject is unable, or unwilling, to comply with the protocol-required follow-up schedule

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 identifier (NCT number): NCT02029885

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Contact: Omar Dawood

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Monash Medical Centre Terminated
Clayton, Australia
Medizinischen Universität Wien -UK für Klinische Pharmakologie Recruiting
Vienna, Austria
Principal Investigator: Michael Wolzt, MD         
Angiografia de Occidente, S.A. Terminated
Cali, Colombia
CHD Cardio Centro de Excelencia SAS Terminated
Cali, Colombia
Czech Republic
St. Anne's University Hospital Active, not recruiting
Brno, Czech Republic
University Hospital Brno Active, not recruiting
Brno, Czech Republic
Městská Nomocnice Ostrava Active, not recruiting
Ostrava, Czech Republic
General University Hospital Withdrawn
Prague, Czech Republic
Nemocnice Na Homolee Hospital Active, not recruiting
Prague, Czech Republic
University Hospital Bonn Recruiting
Bonn, Germany
Principal Investigator: Georg Nickenig, MD         
University Hospital of the University of Erlangen-Nuremberg Recruiting
Erlangen, Germany
Contact: Sabine Thuemmler   
Principal Investigator: Roland Schmieder, MD         
CardioVascular Center Frankfurt - Sankt Katharinen Hospital Recruiting
Frankfurt, Germany
Principal Investigator: Horst Sievert, MD         
University Hospital Hamburg-Eppendorf Recruiting
Hamburg, Germany
Contact: Ulrich Wenzel Oberarzt, MD    +49(40) 7410-50026   
Principal Investigator: Ulrich Wenzel Oberarzt, MD         
Uniklinik Köln Recruiting
Koln, Germany
Contact: Tatjana Schewior    +49 (221) 478 88273   
Principal Investigator: Hannes Reuter         
Universitaetsklinikum Leipzig Recruiting
Leipzig, Germany
Contact: Ursula Banning-Eichenseer    +49 341 9720657   
Principal Investigator: Dierk Scheinert, MD         
Sana CardioMed Nord Recruiting
Luebeck, Germany
Contact: Anke Constantz    +49 451 585 1951   
Principal Investigator: Joachim Weil, MD         
Deutsches Herzzentrum Muenchen Recruiting
Munich, Germany
Contact: Ilka Ott, MD    +49 (89) 1218-4578   
Principal Investigator: Ilka Ott, MD         
Clemens Hospital GmbH Recruiting
Münster, Germany
Principal Investigator: Peter Baumgart, MD         
New Zealand
Mercy Angiography Active, not recruiting
Aukland, New Zealand
Oddział Kliniczny II Kliniki Kardiologii Recruiting
Krakow, Poland
Contact: Dariusz Dudek, MD    +48 12 42 47 181   
Principal Investigator: Dariusz Dudek, MD, PhD         
Institute Of Cardiology Recruiting
Warsaw, Poland
Contact: Adam Witkowski, MD    +48 22 34 34 127   
Principal Investigator: Adam Witkowski, MD, PhD         
United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom
Principal Investigator: Indranil Desgupta, MD, DM, FRCP         
University Hospital Wales Recruiting
Cardiff, United Kingdom
Contact: James Coulson, MD    +44 (0) 7968 366691   
Principal Investigator: James Coulson, MD         
Royal Devon and Exeter Hospital Recruiting
Exeter, United Kingdom
Contact: Andrew Sharp, MD   
Principal Investigator: Andrew Sharp, MD         
University of Glasgow Recruiting
Glasgow, United Kingdom
Principal Investigator: Alan Jardine         
St. Bartholomew's Hospital Recruiting
London, United Kingdom
Contact: Mel Lobo, PhD    +44 (0) 7780 700440   
Principal Investigator: Mel Lobo, MD, PhD         
University College London Withdrawn
London, United Kingdom
Southampton University Hospital Recruiting
Southampton, United Kingdom
Contact: James Wilkinson    +44 (0) 7931 703058   
Principal Investigator: James Wilkinson, PhD FRCP         
Sponsors and Collaborators
Kona Medical Inc.
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Principal Investigator: Roland Schmieder, MD University Hospital of University of Erlangen-Nuremberg

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kona Medical Inc. Identifier: NCT02029885     History of Changes
Other Study ID Numbers: KM14-001
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Keywords provided by Kona Medical Inc.:
Renal Denervation
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases