A Study to Evaluate Renal Fibrosis Using MRI Techniques (NCT04508049) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study to Evaluate Renal Fibrosis Using MRI Techniques
United States24 participantsStarted 2020-10-01
Plain-language summary
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.
Who can participate
Age range40 Years – 80 Years
SexALL
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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…
What they're measuring
1
Fibrosis assessed by qMT-MRI in the stenotic kidney and contralateral kidneys