ESCAPE Mechanistic Substudies

ESCAPE机制子研究

• 批准号: 6538044
• 负责人: ROBERT M CALIFF
• 金额: $ 34.65万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-04-01 至 2004-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6538044
• 关键词: atrial natriuretic peptide; beta antiadrenergic agent; biomarker; blood chemistry; catheterization; congestive heart failure; heart disorder diagnosis; hemodynamics; human subject; mathematical model; outcomes research; pathologic process; patient oriented research; peptide hormone; prognosis; pulmonary artery; troponin

DESCRIPTION (Applicant's Abstract) This proposal is a prospective, observational study designed to evaluate the potential of serum biomarkers to serve both as prognostic indices and as surrogate endpoints for death and hospitalization in heart failure trials. The first goal wlll be accomplished by evaluating relations between levels of natriuretic peptides, troponins, and clinical outcomes. We will develop a risk score for patients with advanced heart failure that incorporates the serum biomarkers and clinical variables and test for interactions between this score and pulmonary artery catheterization. We will also evaluate the ability of serum biomarkers to serve as objective measures of both clinical and hemodynamic status and assess the potential of these markers to serve as tools to assist with the selection and titration of therapies. In addition. we will examine the relations between levels of natriuretic peptides, troponins, and catecholamines. This information will be the launching point for the second goal, which will be to examine the relationship between the serum biomarkers and the treatment effect of pulmonary-artery catheterization on death and hospitalization. In addition, we will evaluate the relations between levels of natriuretic peptides, troponins, and the treatment effects of B-adrenergic antagonists and inotropic agents on clinical outcomes. Ultimately, we intend to construct a statistical model that incorporates the serum biomarkers with greatest promise and clinical variables demonstrated to predict survival. This final model may prove to be the best Surrogate endpoint possible, as it will capture an array of physiological mechanisms through which pulmonary-artery catheter guided therapy may have an effect. This proposed substudy will be conducted within the framework of the ESCAPE trial. Natriuretic peptide levels are currently being collected at randomization, discharge, 1 month, and 6 months as a secondary endpoint of the trial. Catecholamines are also being collected at baseline and 3 months. In addition, the ESCAPE investigators are all ready capturing detailed demographic, clinical, and physiological information as part of the protocol for the primary study.

描述 （申请人摘要）该提案是一项前瞻性观察性研究 旨在评估血清生物标志物作为两者的潜力 预后指数并作为死亡和住院的替代终点 心力衰竭试验。第一个目标将通过评估来实现 利尿钠肽、肌钙蛋白水平与临床的关系 结果。我们将为晚期心脏病患者制定风险评分 结合血清生物标志物和临床变量和测试的失败 该评分与肺动脉导管插入术之间的相互作用。 我们 还将评估血清生物标志物作为客观指标的能力 临床和血流动力学状态的测量并评估潜力 这些标记物可作为工具来协助选择和滴定 疗法。此外。我们将研究各层次之间的关系 利尿钠肽、肌钙蛋白和儿茶酚胺。 该信息将成为第二个目标的启动点，该目标将 检查血清生物标志物与治疗之间的关系 肺动脉导管插入术对死亡和住院治疗的影响。 在 此外，我们将评估尿钠排泄水平之间的关系 肽、肌钙蛋白和 B-肾上腺素能拮抗剂的治疗效果 正性肌力药物对临床结果的影响。 最终，我们打算构建一个统计模型，其中包含 最有希望的血清生物标志物和临床变量被证明 预测生存。 这个最终模型可能被证明是最好的替代模型 终点是可能的，因为它将捕获一系列生理机制 肺动脉导管引导治疗可能会产生效果。 这项拟议的子研究将在 ESCAPE 框架内进行 审判。 目前正在收集利尿钠肽水平 随机化、出院、1 个月和 6 个月作为次要终点 审判。 还在基线和 3 个月时收集儿茶酚胺。在 此外，ESCAPE 调查员已准备好捕捉详细信息 作为方案一部分的人口统计、临床和生理信息 用于初步研究。