Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling

Mayo Clinic

Overview

Researchers are evaluating a noninvasive treatment with ultrasound waves for Atherosclerotic Renal Artery Stenosis (ARAS).

Investigators will study 30 patients with ARAS randomized to SWT or sham (n=15 each) twice a week over 3 weeks. We will measure before and again 3 months after a 3-wk regimen renal cortical and medullary perfusion and function (multi-detector computed tomography \[MDCT\]), oxygenation, and fibrosis (magnetic resonance imaging \[MRI\]), urinary and plasma levels of renal injury markers, systemic endothelial function, and heart rate variability, an index of sympathetic activation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Renal Artery Stenosis

Interventions

Low-energy extracorporeal ultrasound shockwave therapy (SWT)DEVICE

SWT delivers 10% energy of the traditional SWT used for clinically indicated lithotripsy, evokes neovascularization, and improves regional blood flow and function in various ischemic tissues.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patients are between ages 40 and 80 years old. * Patients with hypertension (Systolic BP\> 155 mm Hg) and/or requirement for two or more antihypertensive medications for more than 4 weeks, no restrictions on antihypertensive agents, although loop diuretics may be changed to diluting site agents (e.g. hydrochlorothiazide, indapamide, metolazone) for two weeks prior to study. * Patients have serum creatinine ≤2.2 mg/dL. * Patients have no contraindications to angiography: severe contrast allergy. * Patients have no contraindications to no-contrast MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia. * Patients have the ability to comply with protocol * Patients are competent and able to provide written informed consent Exclusion Criteria * Patient have serum creatinine \>2.2 mg/dL * ARAS in a solitary kidney * Patients have clinically significant medical conditions within the six months before SWT treatment: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient. * Uncontrolled hypertension (Systolic BP \>180 mmHg despite therapy). * Pacemaker, implantable defibrillator or other contraindication to MRI * Inability to comply with breath-hold for 20 seconds * Any active malignancy and undergoing therapy * Patients are pregnant. * Kidney or ureteric stone that may affect the effect of SWT. * Another known acute or chronic kidney disease * Local inflammation or infection over treatment areas. * Bleeding disorders. * Federal medical center inmates. * Latex allergy