Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling

Mayo Clinic

Status: Withdrawn

Conditions: Renal Artery Stenosis

Treatments: Device: Low-energy extracorporeal ultrasound shockwave therapy (SWT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03914157

18-007617

R01HL123160 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

15 patients with ARAS randomized to SWT

Active Comparator group

Description:

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.

Treatment:

Device: Low-energy extracorporeal ultrasound shockwave therapy (SWT)

15 patients with ARAS sham

Sham Comparator group

Description:

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.

Treatment:

Device: Low-energy extracorporeal ultrasound shockwave therapy (SWT)