IMMUNOSUPPRESSIVE THERAPY FOR BIOPSY-PROVEN MYOCARDITIS

这是一项临床研究，旨在确定 免疫抑制治疗改善慢性阻塞性肺疾病患者的心功能 心内膜心肌活检证实为心肌炎。不明原因的患者 心脏功能不全将接受心脏活检。那些被发现犯有 有活动性心肌炎的人将被要求同意这项研究，并将 形成研究人群。他们将在两年的时间里被随机分配 三肢治疗期：充血性心脏的常规治疗 失败，强的松和硫唑嘌呤的免疫抑制，或 环孢素和泼尼松的免疫抑制作用。治疗将是 维持六个月，并有严格的治疗后后续计划 将在此后至少六个月内实行。以前，有一次 在治疗期间和治疗后两次，广泛的评估将包括 心内膜心肌活检，右心血流动力学研究，放射性核素 心血管造影术、二维超声心动图、平板运动试验、动态心电图 监测研究和症状评估。建立了严格的标准 以确定治疗的改善、恶化和失败。数据将是 间歇性检查，以确定是常规治疗还是 免疫抑制的效果更好。疗效的主要决定因素 这项研究是最大运动时间和静息放射性核素的变化 左心室射血分数。几个额外的端点将 检查过了。 临床试验的补充是努力改善我们的 从病理生理学角度认识心肌炎的发病机制 对血液和心肌样本进行广泛的分析。这些分析包括 免疫荧光技术、免疫印迹、免疫过氧化物酶 技术、免疫组织化学、流式细胞术、细胞毒试验、 淋巴细胞亚群功能测定等。的最终目的是 这些研究是为了确定在人类心肌炎中识别的抗原。 并对所涉及的淋巴细胞群进行表征。

This is a clinical research study designed to determine if immunosuppressive treatment improves cardiac function in patients with myocarditis documented by endomyocardial biopsy. Patients with unexplained cardiac dysfunction will undergo cardiac biopsy. Those who are found to have active myocarditis will be asked to consent to this research and will form the study population. They will be randomized during a two year period to three treatment limbs: conventional therapy for congestive heart failure, immunosuppression with prednisone and azathioprine, or immunosuppression with cyclosporine and prednisone. Treatment will be maintained for six months, and a rigorous post-treatment follow-up program will be instituted thereafter for a minimum of six months. Before, once during and twice after therapy, extensive assessment will include endomyocardial biopsy, right heart hemodynamic study, radionuclide angiogram, 2-dimensional echocardiogram, treadmill exercise test, holter monitoring study and symptom assessment. Strict criteria are established to determine improvement, worsening and failure of treatment. Data will be examined intermittently to determine if conventional therapy or either form of immunosuppression is superior. The primary determinants of efficacy in this study are changes in maximum exercise time and resting radionuclide left ventricular ejection fraction. Several additional endpoints will be examined. The clinical trial is supplemented by an effort to improve our understanding of the pathophysiology of myocarditis in humans by means of extensive analysis of blood and myocardial samples. The analyses include immunofluorescent techniques, western immunoblotting, immunoperoxidase technique, immunohistochemistry, flow cytometry cellular cytoxicity assays, lymphocyte subtype function assays and others. The ultimate purpose of these studies is to identify the antigens recognized in human myocarditis and to characterize the lymphocyte populations involved.