(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
基本信息
- 批准号:10445019
- 负责人:
- 金额:$ 36.07万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AfricaAmericanBiological MarkersBreast FeedingBromocriptineCathepsinsCessation of lifeClinical DataClinical ResearchClinical TrialsCollaborationsComplexCongestive Heart FailureCore FacilityCountryData Coordinating CenterDatabase Management SystemsDevelopmentDiagnosisDopamine AgonistsEchocardiographyEuropeanEvaluationGerman populationGuidelinesHeart TransplantationHeart failureHospitalizationInvestigationLeftLeft Ventricular Ejection FractionMaintenanceMaternal MortalityMulti-Institutional Clinical TrialMyocardialNorth AmericaOnline SystemsOutcomePathogenesisPhasePlacebosPostpartum PeriodPredictive ValueProlactinRandomizedRandomized Controlled TrialsRecommendationRecoveryReportingResearch PersonnelSouth AfricanStatistical Data InterpretationSuggestionSystemSystems AnalysisTherapeuticTimeTreatment FailureUnited StatesUniversitiesWomanbasebiobankclinical centercohortdata disseminationdata managementdesignimproved outcomematernal morbiditymortalitymulti-ethnicmulti-racialperipartum cardiomyopathyplacebo groupprimary endpointprogramsprotocol developmentrandomized placebo controlled trialrandomized trialsecondary endpointtreatment grouptrial comparingworking group
项目摘要
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)
仍然是孕产妇发病和死亡的一个主要原因。虽然改善了心肌
超过一半的PPCM妇女在产后12个月内出现功能障碍,
那些没有康复的人会患上慢性心力衰竭,5-10%的妇女死亡或需要
产后第一年进行心脏移植。催乳素的抑制作用
多巴胺受体激动剂溴隐亭似乎改善了三项临床研究的结果
的PPCM。一个欧洲工作组最近提出的建议建议是,
溴隐亭与标准心力衰竭治疗;然而,没有随机试验比较
标准治疗加溴隐亭的标准治疗已在多种族
北美队列。本次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相比可改善PPCM女性患者的预后,
随机对照试验。
匹兹堡大学临床试验与数据协调中心(CCDC)建议,
作为拟定随机评价的数据协调中心(DCC)
溴隐亭治疗围产期心肌病(REBIRTH)研究。我们目前服务于
作为众多单中心和多中心临床试验的DCC,我们支持许多
研究的复杂方面,包括项目管理、方案制定、数据
管理、监管支持、统计分析和数据发布。CCDC将
与研究者合作,设计、实施、协调和分析拟议的
REBIRTH临床试验具体而言,我们建议1)提供方案协调,
在重生的所有阶段(UG 3和UH 3)提供行政支持; 2)协调
在UG 3阶段制定方案,在整个
研究,并建立与关键核心设施的合作; 3)适应和维持现有的
基于网络的数据管理和跟踪系统,
重生;和4)为设计和统计分析提供全面的专业知识,
重生
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kaleab Z Abebe其他文献
Kaleab Z Abebe的其他文献
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{{ truncateString('Kaleab Z Abebe', 18)}}的其他基金
(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:
10703436 - 财政年份:2021
- 资助金额:
$ 36.07万 - 项目类别:
The Pittsburgh Scientific and Data Research Center for the COPE-AKI Consortium (Pitt-SDRC)
COPE-AKI 联盟匹兹堡科学与数据研究中心 (Pitt-SDRC)
- 批准号:
10296801 - 财政年份:2021
- 资助金额:
$ 36.07万 - 项目类别:
The Pittsburgh Scientific and Data Research Center for the COPE-AKI Consortium (Pitt-SDRC)
COPE-AKI 联盟匹兹堡科学与数据研究中心 (Pitt-SDRC)
- 批准号:
10451746 - 财政年份:2021
- 资助金额:
$ 36.07万 - 项目类别:
The Pittsburgh Scientific and Data Research Center for the COPE-AKI Consortium (Pitt-SDRC)
COPE-AKI 联盟匹兹堡科学与数据研究中心 (Pitt-SDRC)
- 批准号:
10670114 - 财政年份:2021
- 资助金额:
$ 36.07万 - 项目类别:
(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:
10213992 - 财政年份:2021
- 资助金额:
$ 36.07万 - 项目类别:
Data Coordinating Center for the Halt-Polycystic Kidney Disease Trials
停止多囊肾病试验数据协调中心
- 批准号:
8658816 - 财政年份:2008
- 资助金额:
$ 36.07万 - 项目类别:
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