Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension (WAVE_IV)
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|ClinicalTrials.gov 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
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|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Device: Investigational Therapy (Surround Sound) Device: Sham Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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
- 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.
- Change in ABPM [ Time Frame: 6 months ]Change in average 24-hour ambulatory blood pressure from screening to the 6 month follow-up visit
- 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.
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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|
- 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;
- 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).
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02029885
|Contact: Omar Dawoodfirstname.lastname@example.org|
|Principal Investigator:||Roland Schmieder, MD||University Hospital of University of Erlangen-Nuremberg|
|Responsible Party:||Kona Medical Inc.|
|Other Study ID Numbers:||
|First Posted:||January 8, 2014 Key Record Dates|
|Last Update Posted:||January 8, 2016|
|Last Verified:||January 2016|