Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005865

Trial Description

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Title

Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension

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Trial Acronym

WAVE_IV

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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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Organizational Data

  •   DRKS00005865
  •   2014/09/10
  •   2014/01/06
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02029885  (ClinicalTrials.gov)
  •   KM14-001  (Kona Medical Inc.)
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Health Condition or Problem studied

  •   Hypertension
  •   I10-I15 -  Hypertensive diseases
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Interventions/Observational Groups

  •   Device: Investigational Therapy (Surround Sound)
  •   Device: Sham Control
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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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.

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Secondary Outcome

- Change in ABPM; time frame: 6 months; Change in average 24-hour ambulatory blood pressure from screening to the 6 month follow-up visit

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Countries of Recruitment

  •   Australia
  •   Austria
  •   Colombia
  •   Czech Republic
  •   Germany
  •   New Zealand
  •   Poland
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/08/31
  •   132
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional 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).

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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

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Addresses

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    • Kona Medical Inc.
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    • University Hospital of University of Erlangen-Nuremberg
    • Roland Schmieder, MD 
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    •   [---]*
    •   [---]*
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    • Omar Dawood 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.