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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02029885




Registration number
NCT02029885
Ethics application status
Date submitted
6/01/2014
Date registered
8/01/2014
Date last updated
8/01/2016

Titles & IDs
Public title
Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension
Scientific title
Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension
Secondary ID [1] 0 0
KM14-001
Universal Trial Number (UTN)
Trial acronym
WAVE_IV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Investigational Therapy (Surround Sound)
Treatment: Devices - Sham Control

Experimental: Investigational Therapy (Surround Sound) - Investigational Therapy using external focused ultrasound

Sham Comparator: Sham Control - Blinded Sham Control Arm


Treatment: Devices: Investigational Therapy (Surround Sound)


Treatment: Devices: Sham Control
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety at 6 weeks follow-up
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Change in OBP
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Change in ABPM
Timepoint [1] 0 0
6 months

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2018
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Colombia
State/province [2] 0 0
Cali
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Brno
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Ostrava
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Prague
Country [6] 0 0
Germany
State/province [6] 0 0
Bonn
Country [7] 0 0
Germany
State/province [7] 0 0
Erlangen
Country [8] 0 0
Germany
State/province [8] 0 0
Frankfurt
Country [9] 0 0
Germany
State/province [9] 0 0
Hamburg
Country [10] 0 0
Germany
State/province [10] 0 0
Koln
Country [11] 0 0
Germany
State/province [11] 0 0
Leipzig
Country [12] 0 0
Germany
State/province [12] 0 0
Luebeck
Country [13] 0 0
Germany
State/province [13] 0 0
Munich
Country [14] 0 0
Germany
State/province [14] 0 0
Münster
Country [15] 0 0
New Zealand
State/province [15] 0 0
Aukland
Country [16] 0 0
Poland
State/province [16] 0 0
Krakow
Country [17] 0 0
Poland
State/province [17] 0 0
Warsaw
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Birmingham
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Cardiff
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Exeter
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Glasgow
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kona Medical Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02029885
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Roland Schmieder, MD
Address 0 0
University Hospital of University of Erlangen-Nuremberg
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Omar Dawood
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02029885