EFFECT OF AMLODIPINE ON SURVIVAL IN PATIENTS WITH CONGESTIVE HEART FAILURE

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Patients with NYHA class III-IV nonischemic cardiomyopathy are invited to take part in a research study using an investigational drug, Amlodipine. Amlodipine has been used for patients with high blood pressure but has not been approved for patients with congestive heart failure . This study is designed to determine if, amlodipine, when given in addition to standard, approved drug therapy, will prolong life for patients with severe heart failure. The precursor to this study, "Praise," demonstrated a positive survival benefit for patients with severe, nonischemic cardiomyopathy when amlodipine was taken in addition to standard, medical therapy. "Praise 2", is being conducted to determine whether these same benefits will be realized when a larger patient population is studied. Approximately 1,800 patients to be enrolled in this study. Patients will be placed into one of the two treatment groups. The groups are as follows: 1) patients will take their existing medications and Amlodipine pills or 2) patients will take their existing medications and inactive pills. The treatment group each patient assigned to will be chosen randomly, similar to a "flip of a coin". Throughout the study patients will take medications each day as directed by the study investigator. The medication schedule cannot be changed unless discussed first with the investigator. This study has been designed so that neither the patient nor the investigator will know into which treatment group a patient has been placed. However, this information will be given to the physician in the case of any emergency or if this becomes essential to care. This study may last anywhere between six months (26 weeks) and three years (143 weeks). The exact length of study participation depends upon when patients enroll in the study. During this time, patients will be required to make up to 14 scheduled visits. During these visits, patients will have a variety of tests and examinations. Examinations required include: a medical history, physical examinations, blood pressure and pulse measurements, and weight measurements. Cardiopulmonary (heart and lung) evaluations will also be performed as well as assessments for edema (swelling). Patients may also be asked to perform one six minute walk test. Information will gathered about any side effects or adverse events that may occur. In addition, information will be gathered if patients are hospitalized. During the study blood samples (2-3 tablespoons per sample) and a urine sample will also be taken. patients will have one electrocardiogram (EKG tracing of the heart) at the beginning of the study and may also be required to have a MUGA scan (pictures to assess the pumping action of the heart).