Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling

Not Applicable

Withdrawn

• Conditions: Renal Artery Stenosis
• Interventions: Device: Low-energy extracorporeal ultrasound shockwave therapy (SWT)

• Registration Number: NCT03914157
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-16
• Study Start: 2023-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-09
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 patients with ARAS randomized to SWT	Low-energy extracorporeal ultrasound shockwave therapy (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.
15 patients with ARAS sham	Low-energy extracorporeal ultrasound shockwave therapy (SWT)	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.

Primary Outcome Measures

Name	Time	Method
Change in renal fibrosis assessed by MRI	Baseline, 3 months	Renal fibrosis as determined by Magnetization transfer imaging (MTI)-MRI in vivo.
Change in kidney perfusion assessed by computed tomography	Baseline, 3 months	Single-kidney perfusion and GFR assessed by multi-detector computed tomography (MDCT)
Change in blood oxygen in kidney assessed by MRI	Baseline, 3 months	Cortical and medullary oxygenation assessed by Blood oxygen-level-dependent (BOLD)-MRI
Change in renal function assessed by GFR	Baseline, 3 months	Renal function by eGFR calculated by both the modified modification of Diet in Renal Disease (MDRD) formula, and measured GFR (mGFR) by iothalamate clearance
Change in urinary levels of biomarkers and extracellular vehicles	Baseline, 3 months	Urinary biomarkers albumin, renal injury markers: Neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecular (KIM)-1, and lactate dehydrogenase (LDH)\], as well as urinary levels of extracellular vehicles (EVs) (measured by flow cytometry) originating from renal microvessels.
Change in labs collected from right and left renal veins and/or Inferior Vena Cava	Baseline, 3 months	Serum creatinine, plasma renin activity (PRA), aldosterone, cytokines and circulating endothelial progenitor cell (EPC) in blood collected from the left and right renal veins and the Inferior Vena Cava (IVC).
Change in mean arterial pressure assessed by oscillometry	Baseline, 3 months	systolic and diastolic BP will be measured by oscillometry to calculate MAP, and assessment of sympathetic nervous system activation by heart rate variability (HRV).
Change in peripheral microvascular endothelial function assessed in the fingertip	Baseline, 3 months	Peripheral microvascular endothelial function by peripheral arterial tonometry (EndoPAT).