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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2016 by Kona Medical Inc.
Sponsor:
Information provided by (Responsible Party):
Kona Medical Inc.
ClinicalTrials.gov Identifier:
NCT02029885
First received: January 6, 2014
Last updated: January 6, 2016
Last verified: January 2016
  Purpose
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 Intervention
Hypertension Device: Investigational Therapy (Surround Sound) Device: Sham Control

Study Type: Interventional
Study Design: 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

Further study details as provided by Kona Medical Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:
  • 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.

  • 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.

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

  • 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.

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

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


Estimated Enrollment: 132
Study Start Date: August 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02029885

Contacts
Contact: Omar Dawood odawood@konamedical.com

Locations
Australia
Monash Medical Centre Terminated
Clayton, Australia
Austria
Medizinischen Universität Wien -UK für Klinische Pharmakologie Recruiting
Vienna, Austria
Principal Investigator: Michael Wolzt, MD         
Colombia
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
Germany
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       sabine.thuemmler@uk-erlangen.de   
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    wenzel@uke.de   
Principal Investigator: Ulrich Wenzel Oberarzt, MD         
Uniklinik Köln Recruiting
Koln, Germany
Contact: Tatjana Schewior    +49 (221) 478 88273    tatjana.schewior@uk-koeln.de   
Principal Investigator: Hannes Reuter         
Universitaetsklinikum Leipzig Recruiting
Leipzig, Germany
Contact: Ursula Banning-Eichenseer    +49 341 9720657    ursula.banning-eichenseer@med.uni-leipzig.de   
Principal Investigator: Dierk Scheinert, MD         
Sana CardioMed Nord Recruiting
Luebeck, Germany
Contact: Anke Constantz    +49 451 585 1951    anke.constantz@sana.de   
Principal Investigator: Joachim Weil, MD         
Deutsches Herzzentrum Muenchen Recruiting
Munich, Germany
Contact: Ilka Ott, MD    +49 (89) 1218-4578    ott@dhm.mhn.de   
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
Poland
Oddział Kliniczny II Kliniki Kardiologii Recruiting
Krakow, Poland
Contact: Dariusz Dudek, MD    +48 12 42 47 181    mcdudek@cyfronet.pl   
Principal Investigator: Dariusz Dudek, MD, PhD         
Institute Of Cardiology Recruiting
Warsaw, Poland
Contact: Adam Witkowski, MD    +48 22 34 34 127    witkowski@hbz.pl   
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    coulsonjm@cardiff.ac.uk   
Principal Investigator: James Coulson, MD         
Royal Devon and Exeter Hospital Recruiting
Exeter, United Kingdom
Contact: Andrew Sharp, MD       andrew.sharp5@nhs.net   
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    m.d.lobo@qmul.ac.uk   
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    james.wilkinson@uhs.nhs.uk   
Principal Investigator: James Wilkinson, PhD FRCP         
Sponsors and Collaborators
Kona Medical Inc.
Investigators
Principal Investigator: Roland Schmieder, MD University Hospital of University of Erlangen-Nuremberg
  More Information

Responsible Party: Kona Medical Inc.
ClinicalTrials.gov Identifier: NCT02029885     History of Changes
Other Study ID Numbers: KM14-001
Study First Received: January 6, 2014
Last Updated: January 6, 2016

Keywords provided by Kona Medical Inc.:
Hypertension
Renal Denervation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2017