A Study to Evaluate Renal Fibrosis Using MRI Techniques
The purpose of this study is to evaluate whether or not an MRI technique (quantitative magnetization transfer or qMT) in narrowing human kidneys is feasible, reproducible, and predicts recovery.
Conditions:
🦠 Hypertension 🦠 Renovascular
🗓️ Study Start (Actual) 1 October 2020
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) September 2025
👥 Enrollment (Estimated) 27
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Between ages 40 and 80 years old.
    • * Patients with hypertension (BP\>140/90 mmHg) and/or requirement for two or more antihypertensive medications for more than 4 weeks.
    • * Serum creatinine under 2.2 and 2.0 mg/dL for men and women, respectively (Caucasians). Values for African-American subjects are slightly higher (2.4 mg/dL, males; 2.1 mg/dL females).
    • * No contraindications to angiography: severe contrast allergy.
    • * 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 has serum creatinine \>2.2 mg/dL for men and \>2.0 mg/dL for women (Caucasians); \>2.4 mg/dL for men and \>2.1 mg/dL for women (African American).
    • * RVD in a solitary kidney
    • * Patients have clinically significant medical conditions within the prior six months: 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).
    • * Diabetes requiring insulin or oral hypoglycemic medications.
    • * Evidence of hepatitis B or C, or HIV infection.
    • * Requirement for potentially nephrotoxic drugs; e.g., non-steroidal anti-inflammatory drugs.
    • * Cardiac ejection fraction less than 30%.
    • * History of deep venous thrombosis within 3 months of enrollment.
    • * Kidney transplant.
    • * 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
    • * Another known acute or chronic kidney disease
    • * Federal medical center inmates.
    • * Latex allergy
Ages Eligible for Study: 40 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 August 2020
  • First Submitted that Met QC Criteria 8 August 2020
  • First Posted 11 August 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 October 2023
  • Last Update Posted 31 October 2023
  • Last Verified October 2023