Drug Research Study for Heart Failure Patients

Study Summary

The University of Chicago and Dr. Allen Anderson are conducting a research study for patients who are hospitalized and have been diagnosed with having acute decompensated heart failure or ADHF. ADHF is the inability of the heart to pump efficiently, which can result in symptoms like shortness of breath at rest or with minimal activity. ADHF is a condition in which the heart cannot perform the necessary circulation of blood through the body.

The aim of this research study is to determine the best dose of an experimental drug in patients hospitalized due to ADHF. The word "experimental" means this drug is still being tested and is not approved by the U.S. Food and Drug Administration (FDA) in the United States. Previous studies with the study drug demonstrated improvement in heart function with minimal side effects. We aim to evaluate the safety and efficacy (how well it works) of three different doses of the drug over a 24-hour continuous intravenous ("IV", through a needle inserted into a vein in the arm) administration. The comparison of the results in the three groups who receive this new drug versus the results in the group who receive placebo (inactive substance which looks like the real drug) will enable us to determine the most appropriate dose to improve heart function and blood circulation in patients like you.

You will be in the study for about 30 days. You will be screened to see if you qualify for participation. If you do, you will be randomized (like rolling dice) 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, chest x-ray, electrocardiogram ("ECG", measures the electrical activity of the heart), and an echocardiogram ("ECHO", a test that uses sound waves to form pictures of the heart).

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 years or older
• Females of childbearing 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:
Linda Bond
lbond@medicine.bsd.uchicago.edu
(773) 702-6385

IRB: #16513A