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Sham Controlled Study of Renal Denervation for Untreated Stage I and II Hypertension

This study is not yet open for participant recruitment.
Verified January 2016 by Kona Medical Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480517
First Posted: June 24, 2015
Last Update Posted: January 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kona Medical Inc.
  Purpose
The Wave VI study is a, multicenter, prospective, double-blind, randomized, sham controlled feasibility study of the safety of renal denervation in patients with stage I and II hypertension who have an average office systolic blood pressure between 150 and 180 mmHg and have not been on any antihypertensive medications for at least six months.

Condition Intervention
Hypertension Device: Ultrasound Device: Sham Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Wave VI Feasibility Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Untreated Stage I and II Hypertension

Further study details as provided by Kona Medical Inc.:

Primary Outcome Measures:
  • Safety will be assessed by incidence of Major Adverse Events (MAE), defined as a composite of the following events: [ Time Frame: 3 months 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 3 months of randomization


  • Change in Office Systolic Blood Pressure (OBP) as measured from screening visit one to the 3 months post randomization follow-up visit. [ Time Frame: Baseline and 3 months ]

Estimated Enrollment: 60
Study Start Date: September 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Therapy (Surround Sound)
Investigational Therapy using external focused ultrasound
Device: Ultrasound
Other Name: Surround Sound
Sham Comparator: Sham Control
Blinded Sham Control Arm
Device: Sham Ultrasound

Detailed Description:
The primary objective of this feasibility study is to assess the safety of renal denervation using externally focused therapeutic ultrasound with non-invasive targeting for patients with stage I and II hypertension who are not on any antihypertensive medications. The key secondary objective is to assess the effect of the therapy on changes from baseline in ambulatory systolic BP.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is at least 18 years of age and no more than 80 years of age and can be safely removed from present antihypertensive therapy.
  2. Subject has not been taking any anti-hypertensive medications for at least 6 months prior to study enrollment.
  3. Subjects must have an average office seated systolic BP (SBP) between 150 mmHg and 180 mmHg inclusive in the untreated state for a minimum of 2 weeks.
  4. Mean daytime ambulatory SBP > 135 mmHg and no more than 170 mmHg in addition to mean daytime ambulatory DBP > 85 mmHg.
  5. Subject has two functioning kidneys.
  6. Subject has an eGFR value of ≥ 30 ml/min/1.73 m² (MDRD formula).

Exclusion Criteria:

a.Any known secondary causes of hypertension.

b.Evidence of current or past history of any clinically significant renal artery stenosis on duplex ultrasound as defined by a finding of at least one of the following:

  1. Peak systolic velocity (PSV) in the main renal artery of 150 cm/s or greater;
  2. Renal/aortic ratio (RAR) of greater than 3.5; or
  3. Complete lack of Doppler signal in any portion of the main renal artery (signifying complete occlusion).

c.Previously documented finding of a 30% or greater renal artery stenosis in any renal arterial vessels as determined by angiographic examination, MRA or CTA.

d.Kidney stones that are 1 cm or greater in size, or that are symptomatic. e.History of intra-abdominal surgery within the past six months or surgery through retroperitoneal path at any time .

f.Previous renal denervation g.Previous renal transplant. h.Heterogeneities in kidney morphology, such as large cysts or tumors (> 2 cm), which are determined at discretion of the investigator to potentially interfere with treatment.

i.Hemodynamically unstable valvular heart disease for which BP reduction would be hazardous in the judgment of the site investigator-physician.

j.Documented history of severe orthostatic hypotension that requires treatment or has necessitated hospitalization.

k.Primary pulmonary hypertension l.History of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.

m.BMI over 35 kg/m² and/or mid-arm circumference > 45 cm (creates difficulty with ABPM measurements) n.Anatomy that precludes treatment as determined by the Surround Sound System. This may include any of the following:

  1. Target treatment depth as measured by the Surround Sound System of greater than 13 cm (Skin to target);
  2. Lack of visualization of the renal artery and or renal artery Doppler signal with the Surround Sound System;
  3. Lack of visualization of the renal parenchyma due to obscuration by bowel or other abdominal or retroperitoneal structures; or
  4. Narrow window between the superior margin of the iliac crest and the inferior margin of the lowest rib that prevents adequate positioning of both the Surround Sound imaging probe and the treatment unit.

o.Subject is pregnant , nursing, or intends to become pregnant during the study period.

p.Enrollment in another interventional research protocol. q.Any condition that, at the discretion of the investigator, would preclude participation in the study.

r.Subject is unable, or unwilling, to comply with the protocol-required follow-up schedule.

  Contacts and Locations
Information from the National Library of Medicine

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): NCT02480517


Contacts
Contact: Omar Dawood odawood@konamedical.com

Sponsors and Collaborators
Kona Medical Inc.
  More Information

Responsible Party: Kona Medical Inc.
ClinicalTrials.gov Identifier: NCT02480517     History of Changes
Other Study ID Numbers: KM14-003
First Submitted: June 21, 2015
First Posted: June 24, 2015
Last Update Posted: January 8, 2016
Last Verified: January 2016

Keywords provided by Kona Medical Inc.:
Hypertension
Renal Denervation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases