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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL123160 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 patients with ARAS randomized to SWT | Active Comparator | 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. |
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| 15 patients with ARAS sham | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in kidney perfusion assessed by computed tomography | Single-kidney perfusion and GFR assessed by multi-detector computed tomography (MDCT) | 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 | Baseline, 3 months |
| Change in blood oxygen in kidney assessed by MRI | Cortical and medullary oxygenation assessed by Blood oxygen-level-dependent (BOLD)-MRI | Baseline, 3 months |
| Change in renal fibrosis assessed by MRI | Renal fibrosis as determined by Magnetization transfer imaging (MTI)-MRI in vivo. | 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. | 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). | Baseline, 3 months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Rajiv Gulati, MD, PhD | Mayo Clinic | Principal Investigator |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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We do not intend to make individual participant data (IPD) available to other researchers.
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| ID | Term |
|---|---|
| D012078 | Renal Artery Obstruction |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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We 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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| 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). | Baseline, 3 months |
| Change in peripheral microvascular endothelial function assessed in the fingertip | Peripheral microvascular endothelial function by peripheral arterial tonometry (EndoPAT). | Baseline, 3 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |