An interventional study of Low-energy extracorporeal ultrasound shockwave therapy (SWT) in Renal Artery Stenosis, sponsored by Mayo Clinic. Withdrawn. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria
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.
Device: 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.
Device: 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.
Change in kidney perfusion assessed by computed tomography
Single-kidney perfusion and GFR assessed by multi-detector computed tomography (MDCT)
Time frame: Baseline, 3 months
Change in renal function assessed by GFR
Renal function by eGFR calculated by both the modified modification of Diet in Renal Disease (MDRD) formula, and measured GFR (mGFR) by iothalamate clearance
Time frame: Baseline, 3 months
Change in blood oxygen in kidney assessed by MRI
Cortical and medullary oxygenation assessed by Blood oxygen-level-dependent (BOLD)-MRI
Time frame: Baseline, 3 months
Change in renal fibrosis assessed by MRI
Renal fibrosis as determined by Magnetization transfer imaging (MTI)-MRI in vivo.
Time frame: Baseline, 3 months
Change in urinary levels of biomarkers and extracellular vehicles
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.
Time frame: Baseline, 3 months
Change in labs collected from right and left renal veins and/or Inferior Vena Cava
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).
Time frame: Baseline, 3 months
Change in mean arterial pressure assessed by oscillometry
systolic and diastolic BP will be measured by oscillometry to calculate MAP, and assessment of sympathetic nervous system activation by heart rate variability (HRV).
Time frame: Baseline, 3 months
Change in peripheral microvascular endothelial function assessed in the fingertip
Peripheral microvascular endothelial function by peripheral arterial tonometry (EndoPAT).
Time frame: Baseline, 3 months
No study locations are listed for this record.
Plan to share: No — We do not intend to make individual participant data (IPD) available to other researchers.
This study is withdrawn, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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