(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

• 批准号: 10449415
• 负责人: DENNIS M. MCNAMARA
• 金额: $ 88.95万
• 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/10449415
• 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

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.

摘要 围产期心肌病（PPCM）是妊娠并发症，发生率为1/2000。 这仍然是孕产妇发病和死亡的主要原因。抑制催乳素 多巴胺能激动剂溴隐亭似乎改善了小规模临床试验的结果， 非洲和欧洲的PPCM研究;然而，在非洲和欧洲没有进行随机试验。 比较溴隐亭与标准心脏的不同种族北美队列 失败疗法这项多中心试验，随机评价溴隐亭在心肌 围产期心肌病恢复治疗（REBIRTH），将评估 在标准治疗中加入溴隐亭可改善PPCM妇女的预后。这 试验将200名患有PPCM的妇女随机分为两组，分别服用溴隐亭或安慰剂8周。左 心室射血分数将在研究入组时通过超声心动图测定， 在随机化后6个月和12个月重新评估，以确定是否添加 溴隐亭可改善左心室功能和总体临床结局。 对于患有PPCM的女性，超声心动图评估左心室功能障碍 重塑有助于预测恢复的可能性该提案将评估是否 整体纵向应变或左心室舒张期容积将预测治疗 对溴隐亭的反应溴隐亭的治疗作用理论上是 催乳素和催乳素片段（统称为血管紧张素）的减少。这 一项研究将调查这些生物标志物的高水平是否预示着更大的益处 溴隐亭母乳喂养会提高催乳素水平，以及母乳喂养对催乳素的影响 PPCM的恢复仍然存在争议。鉴于溴隐亭会导致 哺乳期，患有PPCM的妇女谁想要继续母乳喂养被排除在外， 随机试验这项建议将跟踪50名这样的妇女，并调查这些妇女的水平。 生物标志物和左心室功能的恢复是否在母乳喂养的妇女中不同。 《重生》将阐明溴隐亭在治疗这种疾病中的作用。这项建议 还将评估母乳喂养的影响，并将对整体产生重大影响。 用PPCM管理妇女。