Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT02266394
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT02266394
Study Brief:
Protocol Section:
NCT02266394