(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.

抽象的围产期心肌病 (PPCM) 是一种妊娠并发症，2000 年就有 1 例发生生育仍然是孕产妇发病和死亡的主要原因。抑制催乳素与多巴胺能激动剂溴隐亭一起似乎可以改善小型临床试验的结果非洲和欧洲的 PPCM 研究；然而，尚未进行随机试验不同的多种族北美队列将溴隐亭与标准心脏进行比较失败疗法。这项多中心试验，溴隐亭在心肌中的随机评估围产期心肌病恢复治疗 (REBIRTH) 将评估是否在标准治疗中添加溴隐亭可改善 PPCM 女性的预后。这试验将随机将 200 名患有 PPCM 的女性接受八周的溴隐亭或安慰剂治疗。左边心室射血分数将在研究开始时通过超声心动图确定，并且随机化后 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果。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容积将预测治疗效果对溴隐亭的反应。溴隐亭的治疗作用理论上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越高是否预示着更大的益处来自溴隐亭。母乳喂养会提高催乳素水平，母乳喂养对催乳素的影响 PPCM 的恢复仍存在争议。鉴于溴隐亭会导致停止哺乳期，想要继续母乳喂养的患有 PPCM 的女性被排除在外随机试验。该提案将跟踪 50 名此类女性并调查这些女性的水平母乳喂养妇女的生物标志物以及左心室功能的恢复是否有所不同。 REBIRTH 将阐明溴隐亭治疗这种疾病的作用。这个提议还将评估母乳喂养的影响，并将对整体产生重大影响使用 PPCM 对女性进行管理。