Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension
NCT ID: NCT02029885
Last Updated: 2016-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
132 participants
INTERVENTIONAL
2014-08-31
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sham Control
Blinded Sham Control Arm
Sham Control
Investigational Therapy (Surround Sound)
Investigational Therapy using external focused ultrasound
Investigational Therapy (Surround Sound)
Interventions
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Investigational Therapy (Surround Sound)
Sham Control
Eligibility Criteria
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Inclusion Criteria
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).
Exclusion Criteria
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
18 Years
90 Years
ALL
No
Sponsors
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Kona Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Roland Schmieder, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of University of Erlangen-Nuremberg
Locations
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Monash Medical Centre
Clayton, , Australia
Medizinischen Universität Wien -UK für Klinische Pharmakologie
Vienna, , Austria
Angiografia de Occidente, S.A.
Cali, , Colombia
CHD Cardio Centro de Excelencia SAS
Cali, , Colombia
St. Anne's University Hospital
Brno, , Czechia
University Hospital Brno
Brno, , Czechia
Městská Nomocnice Ostrava
Ostrava, , Czechia
General University Hospital
Prague, , Czechia
Nemocnice Na Homolee Hospital
Prague, , Czechia
University Hospital Bonn
Bonn, , Germany
Uniklinik Köln
Cologne, , Germany
University Hospital of the University of Erlangen-Nuremberg
Erlangen, , Germany
CardioVascular Center Frankfurt - Sankt Katharinen Hospital
Frankfurt, , Germany
University Hospital Hamburg-Eppendorf
Hamburg, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Sana CardioMed Nord
Lübeck, , 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
University College London
London, , United Kingdom
Southampton University Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Saxena M, Shour T, Shah M, Wolff CB, Julu POO, Kapil V, Collier DJ, Ng FL, Gupta A, Balawon A, Pheby J, Zak A, Rull G, O'Brien B, Schmieder RE, Lobo MD. Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success. J Am Heart Assoc. 2018 Jun 12;7(12):e009151. doi: 10.1161/JAHA.118.009151.
Other Identifiers
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KM14-001
Identifier Type: -
Identifier Source: org_study_id
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