(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)是一种妊娠并发症，发生在2000年的活产儿中。 分娩，这仍然是产妇发病率和死亡率的主要原因。催乳素的抑制作用 与多巴胺能激动剂相比，溴隐亭似乎可以改善小型临床患者的预后 非洲和欧洲的PPCM研究；然而，还没有在 北美不同种族的队列比较溴隐亭与标准心脏 失败疗法。溴隐亭在心肌治疗中的多中心随机评价 围产期心肌病(重生)的康复治疗，将评估 在标准治疗的基础上加用溴隐亭可改善PPCM妇女的预后。这 这项试验将200名患有PPCM的女性随机分为溴隐亭或安慰剂治疗8周。左边 心脏射血分数将在研究开始时通过超声心动图进行测定。 在随机化后6个月和12个月重新评估，以确定是否添加 溴隐亭可改善左心功能和总体临床结果。 对于患有PPCM的女性，超声心动图评估左心功能不全 而重塑有助于预测康复的可能性。这项提案将评估是否 整体纵向应变或左心室舒张期容量将预测治疗 对溴隐亭的反应。理论上，溴隐亭的治疗效果是由于 催乳素和催乳素片段的减少统称为血管抑制素。这 调查将调查这些生物标志物水平更高是否预示着更大的好处 来自溴隐亭。母乳喂养提高了催乳素水平，以及母乳喂养对 从PPCM中恢复仍然存在争议。鉴于溴隐亭可导致停止 哺乳期，希望继续母乳喂养的PPCM妇女被排除在 随机试验。这项建议将跟踪50名这样的女性，并调查这些女性的水平 生物标志物和哺乳妇女的左心功能恢复是否不同。 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 PPCM妇女的管理。