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

January 6, 2016 updated by: Kona Medical Inc.

Wave VI Feasibility Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Untreated Stage I and II Hypertension

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Investigational Therapy (Surround Sound)
Investigational Therapy using external focused ultrasound
Device: Ultrasound
Other Names:
  • Surround Sound
Sham Comparator: Sham Control
Blinded Sham Control Arm
Device: Sham Ultrasound

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months follow-up
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
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kona Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KM14-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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