Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling

NCT ID: NCT03914157

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2027-12-31

Brief Summary

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

Detailed Description

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.

Conditions

Renal Artery Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

15 patients with ARAS randomized to SWT

We will study 15 patients with ARAS randomized to SWT 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.

Group Type: ACTIVE_COMPARATOR

Low-energy extracorporeal ultrasound shockwave therapy (SWT)

Intervention Type: 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.

15 patients with ARAS sham

we will study 15 patients with ARAS randomized to or sham 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.

Group Type: SHAM_COMPARATOR

Low-energy extracorporeal ultrasound shockwave therapy (SWT)

Intervention Type: 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.

Interventions

Low-energy extracorporeal ultrasound shockwave therapy (SWT)

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Rajiv Gulati

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajiv Gulati, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

R01HL123160

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-007617

Identifier Type: -

Identifier Source: org_study_id