(2/2) Randomized Evaluation of Bromocriptine In Myocardial Recovery THerapy for Peripartum Cardiomyopathy (REBIRTH)

(2/2) 溴隐亭在围产期心肌病 (REBIRTH) 心肌恢复治疗中的随机评价

• 批准号: 10445019
• 负责人: Kaleab Z Abebe
• 金额: $ 36.07万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10445019
• 关键词: Africa; American; Biological Markers; Breast Feeding; Bromocriptine; Cathepsins; Cessation of life; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Complex; Congestive Heart Failure; Core Facility; Country; Data Coordinating Center; Database Management Systems; Development; Diagnosis; Dopamine Agonists; Echocardiography; European; Evaluation; German population; Guidelines; Heart Transplantation; Heart failure; Hospitalization; Investigation; Left; Left Ventricular Ejection Fraction; Maintenance; Maternal Mortality; Multi-Institutional Clinical Trial; Myocardial; North America; Online Systems; Outcome; Pathogenesis; Phase; Placebos; Postpartum Period; Predictive Value; Prolactin; Randomized; Randomized Controlled Trials; Recommendation; Recovery; Reporting; Research Personnel; South African; Statistical Data Interpretation; Suggestion; System; Systems Analysis; Therapeutic; Time; Treatment Failure; United States; Universities; Woman; base; biobank; clinical center; cohort; data dissemination; data management; design; improved outcome; maternal morbidity; mortality; multi-ethnic; multi-racial; peripartum cardiomyopathy; placebo group; primary endpoint; programs; protocol development; randomized placebo controlled trial; randomized trial; secondary endpoint; treatment group; trial comparing; working group

ABSTRACT The United States has one of the highest rates of maternal mortality in the developed world, and is one of few countries where this rate is increasing. Peripartum cardiomyopathy (PPCM) remains a major cause of maternal morbidity and mortality. While improvement in myocardial function occurs within the first 12 months postpartum in more than half of women with PPCM, those who do not recover are left with chronic heart failure and 5-10% of women die or require cardiac transplantation during the first-year post-partum. Inhibition of prolactin with the dopamine agonist bromocriptine appears to improve outcomes in three previous clinical studies of PPCM. Recent recommendations from a European working group suggest the addition of bromocriptine to standard heart failure therapy; however, no randomized trial comparing standard therapy to standard therapy plus bromocriptine has been performed in a multi-racial North American cohort. The purpose of this investigation is to evaluate whether the addition of bromocriptine to standard heart failure therapy improves outcomes in women with PPCM in a randomized controlled trial. The University of Pittsburgh Center for Clinical Trials & Data Coordination (CCDC) proposes to serve as the Data Coordinating Center (DCC) for the proposed Randomized Evaluation of Bromocriptine Therapy for Peripartum Cardiomyopathy (REBIRTH) study. We currently serve as the DCC for numerous single- and multi-center clinical trials in which we support many complex aspects of the study including project management, protocol development, data management, regulatory support, statistical analyses, and data dissemination. The CCDC will collaborate with study investigators to design, conduct, coordinate, and analyze the proposed REBIRTH clinical trial. Specifically, we propose to 1) provide program coordination and administrative support throughout all phases (UG3 and UH3) of REBIRTH; 2) coordinate protocol development during the UG3 phase, provide regulatory management throughout the study, and establish collaborations with key core facilities; 3) adapt and maintain an existing web-based data management and tracking system to enhance the integrity and rigor of REBIRTH; and 4) provide comprehensive expertise for the design and statistical analysis of REBIRTH.

摘要 美国是发达国家中孕产妇死亡率最高的国家之一， 是少数几个这一比率正在上升的国家之一。围产期心肌病(PPCM) 仍然是产妇发病率和死亡率的主要原因。在改善心肌梗死的同时 超过一半的产后妇女在产后12个月内发生功能障碍， 那些不能康复的人会患上慢性心力衰竭，5%-10%的女性会死亡或需要 产后第一年的心脏移植。对催乳素的抑制作用 在之前的三项临床研究中，多巴胺激动剂溴隐亭似乎改善了结果 PPCM。一个欧洲工作小组最近的建议建议增加 溴隐亭与标准心力衰竭治疗；然而，没有随机试验比较 标准疗法加溴隐亭已在多种族患者中进行。 北美的队列。这项调查的目的是评估是否增加了 溴隐亭与标准心力衰竭治疗可改善PPCM患者的预后 随机对照试验。 匹兹堡大学临床试验和数据协调中心(CCDC)建议 作为拟议的随机评估的数据协调中心(DCC) 溴隐亭治疗围产期心肌病(再生)的研究。我们目前提供的服务 作为众多单中心和多中心临床试验的DCC，在这些试验中，我们支持许多 研究的复杂方面，包括项目管理、协议制定、数据 管理、监管支持、统计分析和数据传播。中共中央疾控中心将 与研究调查人员协作，设计、实施、协调和分析建议 再生临床试验。具体地说，我们建议1)提供计划协调和 在重生的所有阶段(UG3和UH3)提供行政支助；2)协调 在UG3阶段制定协议，在整个过程中提供法规管理 研究并与关键核心设施建立协作关系；3)调整和维护现有 基于Web的数据管理和跟踪系统，以增强数据的完整性和严谨性 重生；以及4)为设计和统计分析提供全面的专业知识 重生。