Research Study for Heart Failure Patients

Study Summary

The University of Chicago and Dr. Stephen Archer are conducting a research study for patients who have been diagnosed with having heart failure. This is a condition in which the heart is enlarged and the heart muscle is weak so that the heart does not pump effectively.

If you agree to participate in this study, your blood will be tested for levels of antibodies to a virus called Adeno-Associated Virus (AAV). Antibodies are Y-shape proteins in your blood that are normally there as part of your immunity (defense) against invading microorganisms (bacteria, viruses). AAV is being studied as a gene transfer agent for a future experimental treatment for heart failure. Antibodies to AAV may interfere and stop the experimental treatment from delivering a gene that might help heart muscle cells that don’t work as well as they could.

Your participation consists of agreeing to donate a blood sample that can be studied for the presence of antibodies to AAV. In addition, your blood sample may be used to develop a new test for AAV antibodies.

If you do not have many antibodies to AAV, you might be eligible for a gene transfer study using AAV, and we would ask if you wanted to hear more details about that study. However, in that study, you are not expected to receive any direct benefit. Additionally, there are no guarantees that you will be eligible to participate in a study, nor is it certain exactly when studies might start or whether or not they will be available at your hospital.

Benefits

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

Participation Details

Initial selection criteria include:

• Must be age 18 to 75 years old
• Must be diagnosed with chronic heart failure
• Must meet study medical criteria as evaluated by Dr. Archer

Study Director: Dr. Stephen Archer
Department: Cardiology

For more information contact:
lbond@medicine.bsd.uchicago.edu
(773) 702-6385

IRB: #16195B