A Study to Determine Effectiveness and Safety of Ultrasound Shockwave Therapy for Post-Stenotic Microvascular Modeling
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-007617
NCT ID: NCT03914157
Sponsor Protocol Number: 18-007617
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.
More information
Publications
Publications are currently not available