LABETALOL TO TREAT CHRONIC CONGESTIVE HEART FAILURE IN CHILDREN & ADOLESCENTS

患有心脏问题的儿童或年轻人有时无法通过手术治愈。这可能会导致许多症状，偶尔需要进行心脏移植。拉贝洛尔可能会改善症状，并有可能减少心脏移植的需要。为了参与这项研究，将对参与者进行筛选，以确保他们符合某些标准：由于心功能下降而导致的稳定充血性心力衰竭。研究对象将接受体检，并进行心电图、超声心动图、运动测试，并抽取2-3茶匙血液进行检测。拉贝洛尔将在诊所连续几周给药，直到确定维持剂量。在确定维持剂量后，受试者将再次接受心电图、超声心动图和运动测试，并在维持治疗6个月后再次接受。在6个月的访问中，将抽取2-3茶匙的血。在维持治疗2个月和4个月后，受试者也将在临床上接受体格检查和耐受性评估。然后，拉贝洛尔治疗将缓慢停止。受试者将在停止拉贝洛尔治疗2周后进行重复的心电图、超声心动图和运动试验。在参与这项研究的过程中，受试者将在临床上被看到大约8-10次。拉贝洛尔的潜在副作用包括低血压、心率减慢或不规则、嗜睡、头晕、疲劳、行为改变、头痛、皮疹、恶心、呕吐、口干、性功能障碍、尿路问题、鼻塞和支气管痉挛。然而，拉贝洛尔的大多数不良反应都是轻微的，短暂的，发生在治疗的早期，可以通过缓慢增加剂量来避免。作为这项研究的一部分，将向参与者提供广泛的测试，受试者或他们的保险提供者不承担任何费用。拉贝洛尔也将免费提供。如果研究药物有预期的效果，参与者可能会体验到症状的减少和心功能的改善。这项研究的结果将为未来开发治疗慢性充血性心力衰竭的新方法提供必要的信息。预计医学、儿童和整个社会都将从这项研究中受益。

Children or young adults with heart problems sometimes cannot be fixed with surgery. This may result in many symptoms and occasionally the need for heart transplantation. Labetalol may improve symptoms and potentially reduce the need for heart transplantation. In order to participate in this study participants will be screened to ensure that they meet certain criteria: stable congestive heart failure as a result of decreased cardiac function. Study subjects will undergo physical examination and have an ECG, echocardiogram, exercise test, and have 2-3 teaspoons of blood drawn for testing. Labetalol will be administered in the clinic on successive weeks until maintenance dosage has been established. Subjects will undergo repeat ECG, echocardiogram, and exercise testing after maintenance dosage has been determined, and again after 6 months of maintenance therapy. At the 6 month visit, 2-3 teaspoons of blood will be drawn. Subjects will also be seen in clinic after 2 and 4 months of maintenance therapy for physical examination and assessment of tolerability. Labetalol therapy will then be discontinued slowly. Participants will undergo repeat ECG, echocardiogram, and exercise testing a final time 2 weeks after labetalol therapy has been discontinued. subjects will be seen in clinic approximately 8-10 times during the course of their involvement in this study. Potential side effects from labetalol include low blood pressure, slow or irregular heart rate, drowsiness, dizziness, fatigue, behavioral changes, headache, rash, nausea, vomiting, dry mouth, sexual dysfunction, urinary problems, nasal congestion, and bronchospasm. However, most adverse effects of labetalol are mild, transient, occur early in therapy, and may be avoided by a slow increase in the dosage. Extensive testing will be provided to participants as part of this study at no cost to subjects or their insurance providers. Labetalol will also be provided at no cost. If the study medication has the expected effects, participants may experience a decrease in symptoms and improved cardiac function. The results of this research will provide information needed to develop new ways to treat chronic congestive heart failure in the future. Medical science, children, and society in general can be expected to benefit from this study.