Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Change in renal fibrosis assessed by MRI
研究概览
简要总结
Researchers are evaluating a noninvasive treatment with ultrasound waves for Atherosclerotic Renal Artery Stenosis (ARAS).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Low-energy extracorporeal ultrasound shockwave therapy (SWT) (Device)
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.
干预措施: Low-energy extracorporeal ultrasound shockwave therapy (SWT) (Device)
结局指标
主要结局
Change in renal fibrosis assessed by MRI
时间窗: Baseline, 3 months
Renal fibrosis as determined by Magnetization transfer imaging (MTI)-MRI in vivo.
Change in kidney perfusion assessed by computed tomography
时间窗: Baseline, 3 months
Single-kidney perfusion and GFR assessed by multi-detector computed tomography (MDCT)
Change in blood oxygen in kidney assessed by MRI
时间窗: Baseline, 3 months
Cortical and medullary oxygenation assessed by Blood oxygen-level-dependent (BOLD)-MRI
Change in renal function assessed by GFR
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline, 3 months
Peripheral microvascular endothelial function by peripheral arterial tonometry (EndoPAT).
次要结局
未报告次要终点