A Study to Determine Effectiveness and Safety of Ultrasound Shockwave Therapy for Post-Stenotic Microvascular Modeling

Overview

About this study

The purpose of this study is to determine if ultrasound waves (SW) treatment changes single kidney blood flow, restores kidney function, increases the number of circulating endothelial progenitor cell (EPC), or lowers high blood pressure.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lilach Lerman, M.D., Ph.D.

Open for enrollment

Contact information:

Department of Medicine – Clinical Trials Unit

(507) 266-1944

RSTDOMCTU@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20455985

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