Research Study for Patients with High Blood Pressure and Renal Artery Stenosis

Study Summary

The University of Chicago and Dr. Sandeep Nathan are conducting a research study for patients who have a history of high blood pressure while on two or more blood pressure medications and a known or suspected renal artery stenosis (narrowing of the blood vessel that supplies blood to your kidney). The purpose of this study is to answer the question: What is the best treatment for patients who have high blood pressure and renal artery stenosis? Currently there is no agreement on diagnosis (identifying the cause or nature of an illness or disease), the method of treatment, or follow-up for patients with blockage (narrowing) in the kidney artery. This study is designed to compare the safety and effectiveness of managing your renal artery stenosis with the use of an experimental device and a blood pressure drug as compared to taking a blood pressure drug alone. The experimental device is a new type of stent (a stainless steel mesh tube that is permanently implanted). It is designed to keep your kidney artery open allowing more blood to flow to your kidney. Metal stents are often placed in other blood vessels, including those of the heart and legs. The stent used in this study is not approved by the Food and Drug Administration (FDA) for commercial use in the kidney. For the purposes of this study, you will be randomly assigned (like the flip of a coin) to one of two groups. One group will receive the stent plus a blood pressure drug and the other group will take a blood pressure drug without receiving the stent.

You will be in this study for about five and a half years. Some of the procedures that will be done during this study are: physical exams, blood and urine testing, completion of questionnaires, ECG test (a recording of the electrical activity of your heart), and any procedures to evaluate for blockages in your kidney arteries. After the initial procedures, you will see a study doctor at two weeks, three months, six months and one year after randomization. After the first year, you will see your study doctor and study nurse twice a year (every six months) until the study is completed.

You will be compensated for your time and gas by payment of a stipend of $50 for your baseline evaluation and $100 for your end-of-study visit and $30 for study-required follow-up visits. This stipend will be paid after each visit.

Benefits

We cannot guarantee or promise you that you will benefit from participating in this study. Participating in this study may benefit others in the future by providing scientific information about high blood pressure and if renal artery stenosis should be treated with a stent and medical therapy, or just medical therapy alone.

Participation Details

Initial selection criteria include:

• Must be at least 18 years of age
• Must not be pregnant or breast feeding during the study
• Must have a history of high blood pressure while on 2 or more blood pressure drugs and a known or suspected renal artery stenosis
• Must meet study medical criteria as evaluated by Dr. Nathan

Study Director: Dr. Sandeep Nathan
Department: Cardiology

For more information contact:
Bridget Galetti, RN
bgaletti@medicine.bsd.uchicago.edu
(773) 702-0347

IRB: #13646A