Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-22 @ 7:01 AM
Study NCT ID:
NCT03914157
Status:
WITHDRAWN
Last Update Posted:
2023-05-09
First Post:
2019-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012078', 'term': 'Renal Artery Obstruction'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to support study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-05', 'studyFirstSubmitDate': '2019-04-09', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in kidney perfusion assessed by computed tomography', 'timeFrame': 'Baseline, 3 months', 'description': 'Single-kidney perfusion and GFR assessed by multi-detector computed tomography (MDCT)'}, {'measure': 'Change in renal function assessed by GFR', 'timeFrame': 'Baseline, 3 months', 'description': 'Renal function by eGFR calculated by both the modified modification of Diet in Renal Disease (MDRD) formula, and measured GFR (mGFR) by iothalamate clearance'}, {'measure': 'Change in blood oxygen in kidney assessed by MRI', 'timeFrame': 'Baseline, 3 months', 'description': 'Cortical and medullary oxygenation assessed by Blood oxygen-level-dependent (BOLD)-MRI'}, {'measure': 'Change in renal fibrosis assessed by MRI', 'timeFrame': 'Baseline, 3 months', 'description': 'Renal fibrosis as determined by Magnetization transfer imaging (MTI)-MRI in vivo.'}, {'measure': 'Change in urinary levels of biomarkers and extracellular vehicles', 'timeFrame': 'Baseline, 3 months', 'description': '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.'}, {'measure': 'Change in labs collected from right and left renal veins and/or Inferior Vena Cava', 'timeFrame': 'Baseline, 3 months', 'description': '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).'}, {'measure': 'Change in mean arterial pressure assessed by oscillometry', 'timeFrame': 'Baseline, 3 months', 'description': 'systolic and diastolic BP will be measured by oscillometry to calculate MAP, and assessment of sympathetic nervous system activation by heart rate variability (HRV).'}, {'measure': 'Change in peripheral microvascular endothelial function assessed in the fingertip', 'timeFrame': 'Baseline, 3 months', 'description': 'Peripheral microvascular endothelial function by peripheral arterial tonometry (EndoPAT).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Renal Artery Stenosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are evaluating a noninvasive treatment with ultrasound waves for Atherosclerotic Renal Artery Stenosis (ARAS).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients are between ages 40 and 80 years old.\n* 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.\n* Patients have serum creatinine ≤2.2 mg/dL.\n* Patients have no contraindications to angiography: severe contrast allergy.\n* Patients have no contraindications to no-contrast MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia.\n* Patients have the ability to comply with protocol\n* Patients are competent and able to provide written informed consent\n\nExclusion Criteria\n\n* Patient have serum creatinine \\>2.2 mg/dL\n* ARAS in a solitary kidney\n* 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.\n* Uncontrolled hypertension (Systolic BP \\>180 mmHg despite therapy).\n* Pacemaker, implantable defibrillator or other contraindication to MRI\n* Inability to comply with breath-hold for 20 seconds\n* Any active malignancy and undergoing therapy\n* Patients are pregnant.\n* Kidney or ureteric stone that may affect the effect of SWT.\n* Another known acute or chronic kidney disease\n* Local inflammation or infection over treatment areas.\n* Bleeding disorders.\n* Federal medical center inmates.\n* Latex allergy'}, 'identificationModule': {'nctId': 'NCT03914157', 'briefTitle': 'Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling', 'orgStudyIdInfo': {'id': '18-007617'}, 'secondaryIdInfos': [{'id': 'R01HL123160', 'link': 'https://reporter.nih.gov/quickSearch/R01HL123160', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '15 patients with ARAS randomized to SWT', 'description': '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.', 'interventionNames': ['Device: Low-energy extracorporeal ultrasound shockwave therapy (SWT)']}, {'type': 'SHAM_COMPARATOR', 'label': '15 patients with ARAS sham', 'description': '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.', 'interventionNames': ['Device: Low-energy extracorporeal ultrasound shockwave therapy (SWT)']}], 'interventions': [{'name': 'Low-energy extracorporeal ultrasound shockwave therapy (SWT)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['15 patients with ARAS randomized to SWT', '15 patients with ARAS sham']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rajiv Gulati, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not intend to make individual participant data (IPD) available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rajiv Gulati', 'investigatorAffiliation': 'Mayo Clinic'}}}}