Clinical trial NCT03914157: Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling
Official title: Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Artery Stenosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-04-16
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We 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.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in kidney perfusion assessed by computed tomography
timeFrame: Baseline, 3 months
measure: Change in renal function assessed by GFR
timeFrame: Baseline, 3 months
measure: Change in blood oxygen in kidney assessed by MRI
timeFrame: Baseline, 3 months
measure: Change in renal fibrosis assessed by MRI
timeFrame: Baseline, 3 months
measure: Change in urinary levels of biomarkers and extracellular vehicles
timeFrame: Baseline, 3 months
measure: Change in labs collected from right and left renal veins and/or Inferior Vena Cava
timeFrame: Baseline, 3 months
measure: Change in mean arterial pressure assessed by oscillometry
timeFrame: Baseline, 3 months
measure: Change in peripheral microvascular endothelial function assessed in the fingertip
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Rajiv Gulati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: