(1/2) Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for Peripartum Cardiomyopathy (REBIRTH)

(1/2) 溴隐亭治疗围产期心肌病（REBIRTH）心肌恢复治疗的随机评价

基本信息

批准号：
10214144
负责人：
DENNIS M. MCNAMARA
金额：
$ 52.79万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
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 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10214144
关键词：
Africa American Biological Markers Breast Feeding Bromocriptine Cathepsins Cessation of life Clinical Clinical Research Congestive Heart Failure Control Groups Diagnosis Disease Disease-Free Survival Dopamine Agonists Echocardiography Europe Evaluation German population Guidelines Heart Transplantation Heart failure Impairment Investigation Lactation Left Left Ventricular Dysfunction Left Ventricular Ejection Fraction Left Ventricular Function Live Birth Maternal Mortality Medical Multicenter Trials Myocardial Outcome Pathogenesis Placebos Postpartum Period Prediction of Response to Therapy Pregnancy Complications Probability Prolactin Randomized Recovery Reporting Role South African Suggestion Therapeutic Time Treatment Failure United States Ventricular Ventricular Remodeling Woman base biobank circulating biomarkers cohort improved improved outcome maternal morbidity multi-racial outcome prediction peripartum cardiomyopathy placebo group predictive marker primary endpoint randomized placebo controlled trial randomized trial secondary endpoint treatment group trial comparing

项目摘要

ABSTRACT Peripartum cardiomyopathy (PPCM) is a complication of pregnancy occurring in 1 in 2000 live births, which remains a major cause of maternal morbidity and mortality. Inhibition of prolactin with the dopaminergic agonist bromocriptine appears to improve outcomes in small clinical studies of PPCM in Africa and Europe; however, no randomized trial has been performed in a diverse multi-racial North American cohort comparing bromocriptine against standard heart failure therapy. This multicenter trial, Randomized Evaluation of Bromocriptine In Myocardial Recovery Therapy for Peripartum Cardiomyopathy (REBIRTH), will evaluate whether the addition of bromocriptine to standard therapy improves outcomes for women with PPCM. This trial will randomize 200 women with PPCM to eight weeks of bromocriptine or placebo. Left ventricular ejection fraction will be determined by echocardiography at study entry, and reassessed at 6 and 12 months after randomization to determine whether the addition of bromocriptine improves left ventricular function and overall clinical outcomes. For women presenting with PPCM, echocardiographic assessment of left ventricular dysfunction and remodeling helps predict the probability of recovery. This proposal will evaluate whether global longitudinal strain or left ventricular diastolic volume will predict the therapeutic response to bromocriptine. The therapeutic impact of bromocriptine is theoretically a result of the reduction of prolactin and prolactin fragments collectively known as vasoinhibins. This investigation will investigate whether higher levels of these biomarkers predict greater benefit from bromocriptine. Breastfeeding raises prolactin levels, and the impact of breastfeeding on recovery from PPCM remains controversial. Given that bromocriptine causes cessation of lactation, women with PPCM who want to continue breastfeeding are excluded from the randomized trial. This proposal will follow 50 such women and investigate the levels of these biomarkers and whether the recovery of left ventricular function differs in breastfeeding women. REBIRTH will clarify the role of bromocriptine for the treatment of this disorder. This proposal will also evaluate the impact of breastfeeding, and will have a significant impact on the overall management of women with PPCM.

抽象的围产节心肌病（PPCM）是2000年1月1日发生的妊娠并发症出生，这仍然是孕产妇发病率和死亡率的主要原因。抑制催乳素随着多巴胺能激动剂溴封然的影响似乎可以改善小临床的预后非洲和欧洲PPCM的研究；但是，在A中没有进行随机试验多种多种族北美队列比较溴irc丁与标准心脏失败疗法。这项多中心试验，在心肌中对溴o不平的随机评估腹膜心肌病（重生）的恢复疗法将评估是否是否在标准疗法中添加溴cr素可以改善PPCM女性的预后。这试验将将200名PPCM的女性随机，至八周的溴封然或安慰剂。左边心室射血分数将通过超声心动图确定，并在研究进入时确定随机分组后6和12个月重新评估，以确定是否添加溴o不般可改善左心室功能和整体临床结果。对于出现PPCM的妇女，左心室功能障碍的超声心动图评估重塑有助于预测恢复的可能性。该建议将评估是否全球纵向应变或左心室舒张压将预测治疗对溴封然的反应。从理论上讲，溴i的治疗影响是催乳素和催乳素片段的还原统称为血管抑制素。这调查将调查较高水平的这些生物标志物能否预测更大的收益来自溴o我。母乳喂养提高催乳素水平，以及母乳喂养的影响从PPCM中恢复仍然存在争议。鉴于溴封然会导致停止哺乳期，有PPCM想要继续母乳喂养的女性被排除在外随机试验。该提议将遵循50名这样的妇女，并调查这些妇女的水平生物标志物以及左心室功能的恢复在母乳喂养女性中是否有所不同。重生将阐明溴张素在治疗这种疾病方面的作用。这个建议还将评估母乳喂养的影响，并将对整体产生重大影响 PPCM妇女的管理。