Research Study for Heart Failure Patients and Healthy Volunteers

Study Summary

The University of Chicago and Dr. Kim Williams are conducting a research study for patients diagnosed with heart failure, which occurs when your heart does not pump as well as it should. This research study will test whether an experimental radioactive drug can help to identify people who may experience future heart-related problems. The study drug is used during certain types of heart imaging procedures, allowing us to view the heart more clearly. The study drug is not currently approved by the Food and Drug Administration (FDA) for use in the United States. The reason for the study is that having heart failure increases the risk of heart-related problems over a person's life. Among factors that affect this risk are the nerves that control the heart's rhythm and its ability to pump effectively. Based upon available data, it is believed that the study drug can help predict future heart-related problems and also a patient's response to treatment for heart failure. In this research study, the research pictures (also known as images) of your heart will be compared against your heart-related health over the next one to two years. In addition, a small number of subjects with no diagnosis of heart failure (healthy volunteers) and of similar age as you will be enrolled in the research study so that their findings can be compared with yours.

You will be in this study for about two years. Participation in this study will require at least three visits to the study doctor (including the hospital/imaging center) to complete the imaging portion of the study. If you are a heart failure patient, you will also see your doctor every three months as part of your normal routine care.

You will be contacted every six weeks after the research imaging by a member of the study staff to ask you questions about your health. Some of the procedures that may be done during the study include physical examinations, medical history, blood tests, pregnancy tests, ECG (tracing of the electrical activity of your heart), and other heart imaging tests.

You will be paid $300 for the initial imaging visit and then $25 per follow up for a possible total of $500 upon completion of the study. You will be paid one payment at the end of the study for the total study visits completed.

Benefits

You may not benefit directly from this research. However, the medical knowledge obtained from this study may be of considerable benefit to help heart patients in the future.

Participation Details

Initial selection criteria include:

• Must be age 18 years or older
• Must have a history of heart failure, or if you are in the control group (healthy volunteers), you must have no evidence of heart disease
• Females of child-bearing potential must have a negative blood pregnancy test in order to participate.
• Must be available for clinic visits for the duration of the study
• Must meet study medical criteria as evaluated by Dr. Williams

Study Director: Dr. Kim Williams
Department: Cardiology

For more information contact:
ebayer@medicine.bsd.uchicago.edu
(773) 702-0347

IRB: #13982A