Heart Failure Therapy in African Americans

STUDY BASICS

Are you an African American who has been diagnosed with congestive heart failure (CHF)? If so, you may be able to participate in a research study to help find out if a blood test can tell us who will respond better to a FDA-approved drug for CHF.

STUDY PURPOSE

Congestive heart failure (CHF) is a condition in which the heart cannot pump enough blood to the body, either because the heart muscles are weakened or the heart is enlarged. Symptoms of CHF include shortness of breath, fatigue, and swelling in the body; typical treatment approaches involve medications called ACE inhibitors (or ARBs) and beta blockers. However, research has shown that a combination of the drugs Isosorbide Dinitrate and Hydralazine (FDC I/H) may be a better treatment for African Americans with CHF, a difference that may be related to genetic factors. Despite the possible benefits of using FDC I/H, it is only prescribed in 25% of cases of CHF in African Americans. The purpose of this study is to see if a genetic blood test can better show who may benefit from treatment with FDC I/H. The FDA has already approved FDC I/H as a treatment for heart failure in African Americans.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• African American
• Diagnosed with congestive heart failure

WHAT PARTICIPANTS CAN EXPECT

This study involves multiple visits that take place every six months for two years. Visits will last about 1-2.5 hours. Telephone contact by the study team will also occur periodically throughout the study. Participants will answer questionnaires, have blood drawn for genetic testing and for future research, have an echocardiogram, and perform a six minute walk test. All participants will also receive the study drug Isosorbide Dinitrate and Hydralazine (FDC I/H). FDC I/H is provided as a pill and is taken three times a day.