Drug 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. This study involves the use of a virus to transport a gene into your heart to try to stimulate the production of an enzyme (a type of protein that initiates chemical reactions) that is reduced in patients with moderate to severe heart failure. The virus containing the gene is infused through a small tube into the arteries of your heart during a procedure called a cardiac catheterization.

The study drug in this study is not approved by the Food and Drug Administration (FDA) for the treatment of heart failure. This study is experimental. It is meant to study the safety, possible harms, and side effects of infusing an experimental gene transfer drug into your heart.

If you participate in this study, it is possible that you may be randomly (like the roll of a dice) assigned to receive a placebo (an inactive substance which looks like the real drug). You will be in the study for about 13 months. You will need to come back to the hospital or clinic for 14 study visits that can take two to six hours each visit, and on visit 1 (Day 0), you will be required to spend the night in the hospital. At the end of the study, you will be contacted by telephone every six months for an additional two years. Some of the procedures that may be done during the study include: medical history & physical examination, chest x-ray, blood tests, electrocardiogram (ECG), echocardiogram, implantable cardioverter defibrillator (ICD) interrogation, exercise test, six minute walk test, questionnaires, cardiac catheterization and angiogram, and administration of the study drug.

Benefits

You may not 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
• Females of childbearing potential must have a negative urine 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. Archer

Study Director: Dr. Stephen Archer
Department: Cardiology

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

IRB: #16197B