Renal Artery StenosisNCT03914157
Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling
A study testing Low-energy extracorporeal ultrasound shockwave therapy (SWT) in people with Renal Artery Stenosis, run by Mayo Clinic.
Trial summary
Researchers are evaluating a noninvasive treatment with ultrasound waves for Atherosclerotic Renal Artery Stenosis (ARAS). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Renal Artery Stenosis
- What is being tested?
- Low-energy extracorporeal ultrasound shockwave therapy (SWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Researchers are evaluating a noninvasive treatment with ultrasound waves for Atherosclerotic Renal Artery Stenosis (ARAS).
Read the 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.
- Conditions
- Renal Artery Stenosis
- Being tested
- Low-energy extracorporeal ultrasound shockwave therapy (SWT)
- Medical subject headings
- Renal Artery Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-energy extracorporeal ultrasound shockwave therapy (SWT)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 15 patients with ARAS randomized to SWT | Active comparator | 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. Receives: Device: Low-energy extracorporeal ultrasound shockwave therapy (SWT) |
| 15 patients with ARAS sham | Sham comparator | 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. Receives: Device: Low-energy extracorporeal ultrasound shockwave therapy (SWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in kidney perfusion assessed by computed tomography
Single-kidney perfusion and GFR assessed by multi-detector computed tomography (MDCT)
Measured: Baseline, 3 months
Change in renal function assessed by GFR
Renal function by eGFR calculated by both the modified modification of Diet in Renal Disease (MDRD) formula, and measured GFR (mGFR) by iothalamate clearance
Measured: Baseline, 3 months
Change in blood oxygen in kidney assessed by MRI
Cortical and medullary oxygenation assessed by Blood oxygen-level-dependent (BOLD)-MRI
Measured: Baseline, 3 months
Change in renal fibrosis assessed by MRI
Renal fibrosis as determined by Magnetization transfer imaging (MTI)-MRI in vivo.
Measured: Baseline, 3 months
Change in urinary levels of biomarkers and extracellular vehicles
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.
Measured: Baseline, 3 months
Change in labs collected from right and left renal veins and/or Inferior Vena Cava
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).
Measured: Baseline, 3 months
Change in mean arterial pressure assessed by oscillometry
systolic and diastolic BP will be measured by oscillometry to calculate MAP, and assessment of sympathetic nervous system activation by heart rate variability (HRV).
Measured: Baseline, 3 months
Change in peripheral microvascular endothelial function assessed in the fingertip
Peripheral microvascular endothelial function by peripheral arterial tonometry (EndoPAT).
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study startMar 2023 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Unable to support study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Artery StenosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Rajiv Gulati, Mayo Clinic
- Investigators
- Rajiv Gulati, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914157
- Sponsor's protocol ID
- 18-007617
- Other IDs
- R01HL123160
- Status last verified
- May 2023
- First submitted
- 9 Apr 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not intend to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Wave Therapy for Post-stenotic Microvascular Remodeling
- ClinicalTrials.gov ID
- NCT03914157
- Acronym / sponsor ID
- 18-007617
- Conditions
- Renal Artery Stenosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to support study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 15 patients with ARAS randomized to SWT | Active comparator | Device: Low-energy extracorporeal ultrasound shockwave therapy (SWT)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. |
| 15 patients with ARAS sham | Sham comparator | Device: Low-energy extracorporeal ultrasound shockwave therapy (SWT)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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-energy extracorporeal ultrasound shockwave therapy (SWT)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. | Device | 15 patients with ARAS randomized to SWT, 15 patients with ARAS sham |
Primary outcome
Change in kidney perfusion assessed by computed tomography
Time frame: Baseline, 3 months
Single-kidney perfusion and GFR assessed by multi-detector computed tomography (MDCT)
Change in renal function assessed by GFR
Time frame: Baseline, 3 months
Renal function by eGFR calculated by both the modified modification of Diet in Renal Disease (MDRD) formula, and measured GFR (mGFR) by iothalamate clearance
Change in blood oxygen in kidney assessed by MRI
Time frame: Baseline, 3 months
Cortical and medullary oxygenation assessed by Blood oxygen-level-dependent (BOLD)-MRI
Change in renal fibrosis assessed by MRI
Time frame: Baseline, 3 months
Renal fibrosis as determined by Magnetization transfer imaging (MTI)-MRI in vivo.
Change in urinary levels of biomarkers and extracellular vehicles
Time frame: Baseline, 3 months
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.
Change in labs collected from right and left renal veins and/or Inferior Vena Cava
Time frame: Baseline, 3 months
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).
Change in mean arterial pressure assessed by oscillometry
Time frame: Baseline, 3 months
systolic and diastolic BP will be measured by oscillometry to calculate MAP, and assessment of sympathetic nervous system activation by heart rate variability (HRV).
Change in peripheral microvascular endothelial function assessed in the fingertip
Time frame: Baseline, 3 months
Peripheral microvascular endothelial function by peripheral arterial tonometry (EndoPAT).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. We do not intend to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajiv Gulati, MD, PhD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Low-energy extracorporeal ultrasound shockwave therapy (SWT) in people with Renal Artery Stenosis, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in kidney perfusion assessed by computed tomography (time frame: Baseline, 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.