IRB Number:

08-006383

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Subjects with heart failure are asked to volunteer in this study. The purpose for this study is to see if adding a drug called spironolactone to the current treatment for heart failure is able to safely improve heart failure. The study aims to examine the safely and effectiveness of spironolactone compared with placebo, which is an inactive drug that serves as pretend treatment (with no active drug in it), in the treatment of adults with heart failure and a certain level of heart contraction. Spironolactone 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 spironolactone that is not approved by the FDA and compares it to placebo to test if the drug has a real effect.

Who is Eligible to Participate in the Study?

Potential: Women of child-bearing potential must have a negative serum/urine pregnancy test within 72 hours prior to randomization, must not be lactating and must agree to use an effective method of contraception during the entire course of study participation.

Minimum Age:

50

Maximum Age:

99

What is Involved With this Study?

You will be asked to sign an informed consent form once you have had all your questions answered and you wish to participate in the study. If you agree to be in the study you will be asked to participate in the following: Your doctor will determine whether your current clinical condition, heart failure symptoms, blood pressure, echo cardiogram results, and certain laboratory tests meets the requirements for the study. After your doctor has decided you are eligible and can safely participate in the study, you will be put in one of 2 groups by chance (as in a flip of a coin) to receive either 1) spironolactone or, 2) placebo. Neither you nor your doctors will know whether or not you are receiving spironolactone or placebo.
You will be given specific instructions about taking the medication and be asked to take the medication every day for at least two years and up to four and a half years as part of the study. After 4 weeks and at 4 months, the dose of the medication may be increased. During the first four months of the study you will have safety laboratory visits to collect blood (about two tablespoons) one week after any change in the study medication dosage, or levels.
In addition, you will have study visit follow-up at 1 week, 5 weeks, 8 weeks, 4 months and then every for months for the 1st year and every 6 months thereafter for 2 to 4.5 years. Study visits will include medical history, physical exam: height, weight, pulse rate, blood pressure, blood collection (about 2 tablespoons) and urine collection (also about two tablespoons). An electrocardiogram, a tracing of the heart, will be done at the beginning of the study. You will be asked to complete 4 patient questionnaires at the beginning of the study, 4 months, 12 months, and then annually after that. Each visit will take about 30-60 minutes to complete. We will ask you to come for the follow-up visits even if you are no longer on the study medication and do not want to come in for follow-up visits. Your study doctor will continue to contact you by telephone or by mail to see how you are. If you do not want your study doctor to monitor you by reviewing your medical records, you must submit your wishes in writing to your study doctor.

How long will the Study run?

You will be in the study for 54 months.

This telephone number has an answering machine.

Who can I Contact for Additional Information on this Trial?

Dana G. Kontras RN MSN Clinical Studies Unit
Telephone (904) 953-8557

What is/are the Locations of this Clinical Trial?

• Jacksonville, FL

Last updated: 02/02/2009