Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling

Renal Artery Stenosis Clinical Trial

Official title:

Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03914157
• Other study ID #: 18-007617
• Secondary ID: R01HL123160
• Status: Withdrawn
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 2027

Study information

• Verified date: May 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in kidney perfusion assessed by computed tomography	Single-kidney perfusion and GFR assessed by multi-detector computed tomography (MDCT)	Baseline, 3 months
Primary	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
Primary	Change in blood oxygen in kidney assessed by MRI	Cortical and medullary oxygenation assessed by Blood oxygen-level-dependent (BOLD)-MRI	Baseline, 3 months
Primary	Change in renal fibrosis assessed by MRI	Renal fibrosis as determined by Magnetization transfer imaging (MTI)-MRI in vivo.	Baseline, 3 months
Primary	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
Primary	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
Primary	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
Primary	Change in peripheral microvascular endothelial function assessed in the fingertip	Peripheral microvascular endothelial function by peripheral arterial tonometry (EndoPAT).	Baseline, 3 months

External Links

•   Mayo Clinic Clinical Trials