Drug Research Study for Heart Failure Patients

Study Summary

Heart failure occurs when your heart muscle gradually weakens and your heart becomes less able to pump blood throughout the body. The University of Chicago and Dr. Allen Anderson are conducting a research study is to see if adding a drug to your current treatments for heart failure will safely improve your heart failure. Therefore, this study aims to examine the safety and effectiveness of the study drug compared with placebo (a substance that does not contain drug, like a sugar pill) in the experimental treatment of adults with heart failure.

The drug used in this study is a "potassium-sparing" diuretic drug that removes extra fluid and prevents salt retention. This drug is used to treat people with congestive heart failure, which is a more severe form of heart failure. The study drug is approved by the Food and Drug Administration (FDA) for the treatment of congestive heart failure. However, this study uses a lower starting dosage of the drug that is not approved by the FDA and compares it to placebo to test if the drug has a real effect. This use of the drug is experimental since the study is trying to determine if adding it to usual therapy helps improve heart failure and level of heart contraction.

This is a randomized (like a flip of a coin), controlled, double blind study. Neither you nor your doctor will know if you get study drug or placebo ("sugar pill") during the study.

This study will last 4 ½ years. Your total time involved will depend on when you were enrolled in the study. It will be at least two years, and not more than 4 ½ years. You will be screened to see if you qualify for participation. If you do, you will be randomized to study drug or placebo. Some of the procedures that may be done during the study include physical examinations, medical history, blood and urine testing, ECG (tracing of the electrical activity of your heart), and questionnaires.

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 50 years or older
• Must have a history of heart failure
• Must have a certain level of heart contraction measured (like the force of your heart's pumping action) within the last six months.
• 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. Anderson

Study Director: Dr. Allen Anderson
Department: Cardiology

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

IRB: #14615B