TOPCAT Clinical Trial

Treatment of Preserved Cardiac function heart failure with an Aldosterone anTagonist

Purpose:

To see if adding a drug called spironolactone to a patient's current treatments for heart failure is able to safely improve his/her heart failure.

Principal Investigator:

Alex Adler MD,
Cardiologist/Heart Failure Specialist
Methodist Heart, Lung and Vascular Institute

Co-Investigators:

Igor Singer, MD
Omar Ali, MD
William Novak, MD
Breno Pessanha, MD
Methodist Heart, Lung and Vascular Institute

For More Information Contact:

Susan Copp, MS, RN
Clinic Site Research Coordinator
(309) 672-4674
suecopp@mmci.org

Summary:

This study involves research and the purpose of this study is to determine the safety and effectiveness of spironolactone in the treatment of adults with heart failure. Patients with a history of heart failure and a certain level of heart contraction measured within the last 6 months (45% or greater ejection fraction) may be eligible to participate. Spironolactone is a "potassium-sparing" drug that removes extra fluid and prevents salt retention. Spironolactone is currently used to treat people with congestive heart failure and is approved by the Food and Drug Administration (FDA) for the treatment of congestive heart failure. This research study uses a lower starting dosage of Spironolactone and compares it to placebo, which is an inactive drug that serves as pretend treatment to test if the drug has a real effect. The effectiveness and benefit of the drug at lower and varying doses is not known. Patients will be divided into 2 groups at random (much like tossing a coin). One group will receive spironolactone; the other group will get a placebo. The study doctor and nurse will not know which treatment has been assigned. Your participation in the study will last between two to four and a half years depending on the progress of the study and when you are enrolled. You will be asked to take study medication every day until the end of the study. Study visits will occur at 1 week, 4 weeks, 5 weeks, 8 weeks, 4 months, and every 4 months during the first year and every 6 months for the remainder of the study. Visits include a physical exam, blood and urine collection, an electrocardiogram, and quality of life questions. Your study doctor will explain all potential known risks with you prior to your participation.

The TOPCAT clinical trial is sponsored by the National Heart, Lung and Blood Institute (NHLBI), which is part of the National Institutes of Health and the Department of Health and Human Services, United States (NIH/DHHS). The New England Research Institutes, Inc. in Watertown, MA and Brigham and Women's Hospital in Boston, MA will serve as the Clinical Trial Coordinating Center (CTCC).