Clinical trial NCT02029885: Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension
Official title: Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Renal Denervation
Lead sponsor: Kona Medical Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-08
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

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

Primary outcomes:
measure: Safety at 6 weeks follow-up
timeFrame: 6 weeks
measure: Change in OBP
timeFrame: 6 months
Secondary outcomes:
measure: Change in ABPM
timeFrame: 6 months
Other outcomes:
measure: Chronic Safety
timeFrame: 6 months
measure: Reduction in blood pressure
timeFrame: 6 months
measure: Incidence of achieving target OBP
timeFrame: 6 months
measure: Reduction in anti-hypertensive medications
timeFrame: 6 months
measure: Changes in OBP
timeFrame: 24 months
measure: Changes in HR
timeFrame: 6 months
Locations:
city: Clayton
country: Australia
facility: Monash Medical Centre
city: Vienna
country: Austria
facility: Medizinischen Universität Wien -UK für Klinische Pharmakologie
city: Cali
country: Colombia
facility: Angiografia de Occidente, S.A.
city: Cali
country: Colombia
facility: CHD Cardio Centro de Excelencia SAS
city: Brno
country: Czech Republic
facility: St. Anne's University Hospital
city: Brno
country: Czech Republic
facility: University Hospital Brno
city: Ostrava
country: Czech Republic
facility: Městská Nomocnice Ostrava
city: Prague
country: Czech Republic
facility: General University Hospital
city: Prague
country: Czech Republic
facility: Nemocnice Na Homolee Hospital
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Erlangen
country: Germany
facility: University Hospital of the University of Erlangen-Nuremberg
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt - Sankt Katharinen Hospital
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
city: Koln
country: Germany
facility: Uniklinik Köln
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Luebeck
country: Germany
facility: Sana CardioMed Nord
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Münster
country: Germany
facility: Clemens Hospital GmbH
city: Aukland
country: New Zealand
facility: Mercy Angiography
city: Krakow
country: Poland
facility: Oddział Kliniczny II Kliniki Kardiologii
city: Warsaw
country: Poland
facility: Institute Of Cardiology
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital Wales
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Glasgow
country: United Kingdom
facility: University of Glasgow
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: London
country: United Kingdom
facility: University College London
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
affiliation: University Hospital of University of Erlangen-Nuremberg
name: Roland Schmieder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.