Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension
- Conditions
- Hypertension
- Interventions
- Device: Sham ControlDevice: Investigational Therapy (Surround Sound)
- Registration Number
- NCT02029885
- Lead Sponsor
- Kona Medical Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 132
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Control Sham Control Blinded Sham Control Arm Investigational Therapy (Surround Sound) Investigational Therapy (Surround Sound) Investigational Therapy using external focused ultrasound
- Primary Outcome Measures
Name Time Method Change in OBP 6 months Change in Office Systolic Blood Pressure (OBP) as measured from screening visit one to the 6 month post randomization follow-up visit.
Safety at 6 weeks follow-up 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
- Secondary Outcome Measures
Name Time Method Change in ABPM 6 months Change in average 24-hour ambulatory blood pressure from screening to the 6 month follow-up visit
Trial Locations
- Locations (28)
Medizinischen Universität Wien -UK für Klinische Pharmakologie
🇦🇹Vienna, Austria
Angiografia de Occidente, S.A.
🇨🇴Cali, Colombia
CHD Cardio Centro de Excelencia SAS
🇨🇴Cali, Colombia
University Hospital Brno
🇨🇿Brno, Czech Republic
General University Hospital
🇨🇿Prague, Czech Republic
University College London
🇬🇧London, United Kingdom
Southampton University Hospital
🇬🇧Southampton, United Kingdom
Monash Medical Centre
🇦🇺Clayton, Australia
St. Anne's University Hospital
🇨🇿Brno, Czech Republic
Městská Nomocnice Ostrava
🇨🇿Ostrava, Czech Republic
Nemocnice Na Homolee Hospital
🇨🇿Prague, Czech Republic
University Hospital of the University of Erlangen-Nuremberg
🇩🇪Erlangen, Germany
University Hospital Bonn
🇩🇪Bonn, Germany
CardioVascular Center Frankfurt - Sankt Katharinen Hospital
🇩🇪Frankfurt, Germany
University Hospital Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Uniklinik Köln
🇩🇪Koln, Germany
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Sana CardioMed Nord
🇩🇪Luebeck, Germany
Deutsches Herzzentrum Muenchen
🇩🇪Munich, Germany
Clemens Hospital GmbH
🇩🇪Münster, Germany
Mercy Angiography
🇳🇿Aukland, New Zealand
Oddział Kliniczny II Kliniki Kardiologii
🇵🇱Krakow, Poland
Institute Of Cardiology
🇵🇱Warsaw, Poland
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
University Hospital Wales
🇬🇧Cardiff, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
University of Glasgow
🇬🇧Glasgow, United Kingdom
St. Bartholomew's Hospital
🇬🇧London, United Kingdom