Status:
COMPLETED
Hypoxia and Inflammatory Injury in Human Renovascular Hypertension
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
University of Mississippi Medical Center
University of Alabama at Birmingham
Conditions:
Renal Artery Stenosis
Ischemic Nephropathy
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
Brief Summary
Current treatments for ARAS based on restoring blood flow alone have been unsuccessful at recovering kidney function. For this reason we are studying a stem cell product called "mesenchymal stem cells...
Detailed Description
These studies include participation by human subjects using a 3-day inpatient CRU protocol at St. Mary's Hospital. Studies include formal measurement of blood and urinary markers of kidney function, B...
Eligibility Criteria
Inclusion
- Creatinine \<2.2 mg/dL for Caucasian males, \<2.0 Caucasian females,\< 2.4 African-American males, \<2.1 mg/dL African-American females
- Hypertension (Systolic BP\>155 mm Hg) and/or requirement for two or more antihypertensive medications: no restrictions on antihypertensive agents, although loop diuretics will be changed to diluting site agents (e.g. hydrochlorothiazide, indapamide, metolazone) prior to study.
- Angiotensin Converting Enzyme (ACE inhibitor) or Angiotensin Receptor Blocker (ARB) therapy maintained or initiated at usual recommended daily dose (equivalent: 40 mg lisinopril) .
Exclusion
- Diabetes requiring insulin or oral hypoglycemic medications (see text)
- Known allergy to furosemide or iodinated intravenous contrast
- Pregnancy
- Recent Cardiovascular event: Myocardial infarction, stroke, congestive heart failure within 3 months
- Cardiac ejection fraction less than 30%
- Evidence of hepatitis B or C, or HIV infection
- requirement for potentially nephrotoxic drugs, e.g. non-steroidal anti-inflammatory drugs
- Uncontrolled hypertension: SBP \>180 mm Hg, despite antihypertensive therapy
- Kidney transplant
- Pacemaker, implantable defibrillator or other contraindication to Magnetic resonance imaging
- Inability to comply with breath-hold for 30 seconds
- History of deep venous thrombosis within 3 months of enrollment
- contraindications to renal biopsy including artificial valve requiring continuous anticoagulation
Key Trial Info
Start Date :
October 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02266394
Start Date
October 21 2014
End Date
September 25 2020
Last Update
January 27 2021
Active Locations (3)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Mayo Clinic
Rochester, Minnesota, United States, 55902
3
University of Mississippi
Jackson, Mississippi, United States, 39216