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Ultrasound Wave Therapy

15 patients with ARAS randomized to SWT for Renal Artery Stenosis

N/A

Waitlist Available

Led By Lilach O Lerman

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months

Awards & highlights

Study Summary

This trial is testing whether a new, non-invasive treatment using ultrasound waves can improve blood flow in the kidney for patients with a specific type of artery disease.

Eligible Conditions

Renal Artery Stenosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in blood oxygen in kidney assessed by MRI

Change in kidney perfusion assessed by computed tomography

Change in labs collected from right and left renal veins and/or Inferior Vena Cava

+5 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 15 patients with ARAS randomized to SWTActive Control1 Intervention

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.

Group II: 15 patients with ARAS shamPlacebo Group1 Intervention

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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Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,784 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,306,496 Total Patients Enrolled

Lilach O LermanPrincipal Investigator - Mayo Clinic

Mayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals of a more advanced age eligible for this research endeavor?

"This medical trial seeks out individuals aged 40 to 80 years old as participants."

Answered by AI

Is this study currently seeking participants?

"As per the clinicaltrials.gov database, this medical trial has concluded recruitment; having first been posted on March 1st 2023 and last updated April 13th 2022. Nevertheless, there are seven other trials that currently require participant enrolment."

Answered by AI

May I participate in this medical experiment?

"This clinical trial is currently sourcing 30 volunteers aged between 40 and 80 who are suffering from renal artery stenosis. Patients must additionally meet the following prerequisites: no allergic reaction to contrast agents, diastolic BP below 155 mm Hg or need for two antihypertensive medications in the past 4 weeks, serum creatinine levels at 2.2 mg/dL or lower, able to tolerate non-contrast MRI scans (e.g. no metal fragments present), demonstrate compliance with protocols and provide informed consent through written agreement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling

Rajiv Gulati 2023. "Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03914157.