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
|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.
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|