Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension

Hypertension Clinical Trial

— WAVE_IV  

Official title:

Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02029885
• Other study ID #: KM14-001
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2014
• Last updated: January 6, 2016
• Start date: August 2014
• Est. completion date: March 2018

Study information

• Verified date: January 2016
• Source: Kona Medical Inc.
• Contact: Omar Dawood
• Email: odawood[@]konamedical.com
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: March 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Investigational Therapy (Surround Sound)

• Sham Control

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Clayton
Austria	Medizinischen Universität Wien -UK für Klinische Pharmakologie	Vienna
Colombia	Angiografia de Occidente, S.A.	Cali
Colombia	CHD Cardio Centro de Excelencia SAS	Cali
Czech Republic	St. Anne's University Hospital	Brno
Czech Republic	University Hospital Brno	Brno
Czech Republic	Mestská Nomocnice Ostrava	Ostrava
Czech Republic	General University Hospital	Prague
Czech Republic	Nemocnice Na Homolee Hospital	Prague
Germany	University Hospital Bonn	Bonn
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	Uniklinik Köln	Koln
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Sana CardioMed Nord	Luebeck
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	Clemens Hospital GmbH	Münster
New Zealand	Mercy Angiography	Aukland
Poland	Oddzial Kliniczny II Kliniki Kardiologii	Krakow
Poland	Institute Of Cardiology	Warsaw
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Kona Medical Inc.

Countries where clinical trial is conducted

Australia,  Austria,  Colombia,  Czech Republic,  Germany,  New Zealand,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chronic Safety	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.	6 months	Yes
Other	Reduction in blood pressure	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.	6 months	No
Other	Incidence of achieving target OBP	Incidence of achieving target OBP (< 140 mmHg) through the 6 month follow-up period.	6 months	No
Other	Reduction in anti-hypertensive medications	Incidence of reductions in the number of anti-hypertensive medications and reductions in the doses of anti-hypertensive medications.	6 months	No
Other	Changes in OBP	Changes in OBP from screening to the 12, 18, and 24 month follow-up periods.	24 months	No
Other	Changes in HR	Changes in HR (as measured by OBP and ABPM) through the 6 month follow-up period.	6 months	No
Primary	Safety at 6 weeks follow-up	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	6 weeks	Yes
Primary	Change in OBP	Change in Office Systolic Blood Pressure (OBP) as measured from screening visit one to the 6 month post randomization follow-up visit.	6 months	No
Secondary	Change in ABPM	Change in average 24-hour ambulatory blood pressure from screening to the 6 month follow-up visit	6 months	No