EFFECT OF AMLODIPINE ON SURVIVAL IN PATIENTS WITH CONGESTIVE HEART FAILURE

NYHA III-IV级非缺血性心肌病患者被邀请参加一项使用研究药物氨氯地平的研究。氨氯地平已被用于高血压患者，但尚未被批准用于充血性心力衰竭患者。这项研究旨在确定氨氯地平在标准的、经批准的药物治疗之外是否会延长严重心力衰竭患者的生命。这项研究的前身“PROSPESS”显示，在标准药物治疗的基础上加用氨氯地平，对严重的非缺血性心肌病患者有积极的生存益处。“表扬2”正在进行，以确定当研究更大的患者群体时，是否会实现这些相同的好处。约1800名患者将被纳入这项研究。患者将被分成两个治疗组中的一个。这些分组如下：1)患者将服用他们现有的药物和氨氯地平药片，或2)患者将服用他们现有的药物和非活性药物。每一位患者分配到的治疗组将被随机选择，就像掷硬币一样。在整个研究过程中，患者将按照研究调查员的指示每天服用药物。除非事先与研究人员讨论，否则不能更改用药时间表。这项研究的设计是这样的，患者和研究人员都不知道患者被分到了哪个治疗组。然而，在任何紧急情况下或如果这成为必要的护理，这些信息将被提供给医生。这项研究可能持续6个月(26周)到3年(143周)。参与研究的确切时间长短取决于患者何时参加研究。在此期间，患者将被要求进行最多14次预定的就诊。在这些探视期间，患者将接受各种测试和检查。要求的检查包括：病史、体检、血压和脉搏测量以及体重测量。还将进行心肺(心脏和肺脏)评估以及对浮肿(肿胀)的评估。患者也可能被要求进行一次6分钟的步行测试。将收集有关可能发生的任何副作用或不良事件的信息。此外，如果患者住院，将收集信息。在研究期间，还将采集血液样本(每个样本2-3汤匙)和尿样。患者将在研究开始时做一次心电图(心脏的EKG跟踪)，还可能需要进行MUGA扫描(评估心脏泵血活动的图片)。

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).