LABETALOL TO TREAT CHRONIC CONGESTIVE HEART FAILURE IN CHILDREN & ADOLESCENTS

拉贝洛尔治疗儿童慢性充血性心力衰竭

• 批准号: 6297019
• 负责人: COLLIN G COWLEY
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6297019
• 关键词: adolescence (12-20); alpha antiadrenergic agent; beta antiadrenergic agent; cardiovascular stress test; child (0-11); clinical research; clinical trials; congestive heart failure; echocardiography; electrocardiography; heart disorder chemotherapy; heart function; human subject; human therapy evaluation; pediatric pharmacology; quality of life

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.

患有心脏病的儿童或年轻人有时无法通过手术修复。 这可能导致许多症状，偶尔需要心脏移植。 拉贝洛尔可以改善症状，并可能减少心脏移植的需要。为了参与本研究，将对受试者进行筛选，以确保他们符合某些标准：由于心脏功能下降导致的稳定充血性心力衰竭。研究受试者将接受体格检查，并进行ECG、超声心动图、运动试验，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，直至确定维持剂量。 受试者将在确定维持剂量后重复进行ECG、超声心动图和运动试验，并在维持治疗6个月后再次进行。 在6个月访视时，将抽取2-3茶匙血液。 受试者还将在维持治疗2个月和4个月后在诊所接受体格检查和耐受性评估。 然后缓慢停止拉贝洛尔治疗。受试者将在拉贝洛尔治疗停止后2周进行最后一次重复ECG、超声心动图和运动试验。在参与本研究的过程中，受试者将在诊所就诊约8-10次。拉贝洛尔的潜在副作用包括低血压、心率缓慢或不规则、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、泌尿问题、鼻塞和支气管痉挛。 然而，拉贝洛尔的大多数不良反应是轻微的，短暂的，发生在治疗的早期，可以通过缓慢增加剂量来避免。作为本研究的一部分，将向受试者提供广泛的测试，受试者或其保险提供商无需承担任何费用。 拉贝洛尔也将免费提供。 如果研究药物具有预期效果，则受试者可能会出现症状减轻和心脏功能改善。这项研究的结果将为将来开发治疗慢性充血性心力衰竭的新方法提供所需的信息。 医学、儿童和整个社会都有望从这项研究中受益。