A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension

NCT01638195 | Completed Phase 1

• 1 other identifier: KM11-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-institution trial wherein twenty subjects with refractory hypertension will receive the experimental focused ultrasound renal denervation therapy. Safety will be assessed by incidence and evaluation of serious adverse effects associated with the investigational procedure through 52-week evaluation of bilateral treatment. Clinical utility will also be evaluated by comparison pre and post therapy systolic and diastolic blood pressure and norepinephrine spillover.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Safety

  Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Included in this assessment will be the proportion of subjects with any of the following outcomes: (1) death, or (2) medical morbidity, including but not limited to renal artery aneurysm, stenosis, significant deterioration of renal function, fistulae or urethral stenosis.

  52 weeks post-treatment

Secondary Outcomes (1)

• Blood Pressure Reduction

  52 weeks post-treatment

Study Arms (1)

Externally Focused Ultrasound

EXPERIMENTAL

Device: Focused Ultrasound

Interventions

Focused Ultrasound DEVICE

Focused Ultrasound

Externally Focused Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years of age.
• Subject has systolic blood pressure of 160 mmHg or greater.
• Subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
• Subject has two functioning kidneys, defined as eGFR ≥ 60 ml/min.

You may not qualify if:

• Subject has history of nephrectomy, kidney tumor or hydronephrosis.
• Subject has renal stenosis greater than 50%.
• Subject has presence of accessory renal artery with lumen ≥ 3 mm.
• Subject has a renal stent.
• Subject has end stage renal disease requiring dialysis or renal implant.
• Subject has Serum Cr \> 3.0 mg/dL or equivalent calculated Glomerular Filtration Rate (GFR).
• Subject has a history of kidney stones.
• Subject has a history of abdominal surgery.
• Subject has a history of heterogeneities in the kidney such as cysts or tumors.
• Subject has a history of pyelonephritis.
• Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
• Subject has hemodynamically significant valvular heart disease.
• Subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI.
• Subject has a body weight \> 150 kilograms.
• Subject has a target treatment depth \> 14 cm.

Sponsors & Collaborators

• Kona Medical Inc.: lead

Study Sites (1)

St. Vincent's Hospital

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert Whitbourn, M.D.

  St Vincent's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2012
• First Posted: July 11, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

AU (1)