GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment (CCC)

使用生物标志物强化治疗 (CCC) 指导循证治疗

• 批准号: 8479426
• 负责人: GARY M FELKER
• 金额: $ 488.35万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-08 至 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8479426
• 关键词: Accounting; Address; Adrenergic beta-Antagonists; Affect; American; Angiotensin-Converting Enzyme Inhibitors; Behavior; Biological Markers; Cardiovascular system; Cause of Death; Cessation of life; Chronic; Clinical; Clinical Treatment; Clinical Trials; Complex; Cost Control; Data; Data Coordinating Center; Disease Management; Dose; Economics; Guidelines; Heart failure; Hospitalization; Hospitals; Lead; Life; Long-Term Effects; Measurement; Medical; Meta-Analysis; Modeling; Morbidity - disease rate; Myocardium; NT-proBNP; National Heart, Lung, and Blood Institute; Natriuretic Peptides; Outcome; Patients; Performance; Physiological; Preventive; Provider; Public Health; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Resources; Strategic Planning; Stress; Systolic heart failure; Testing; Therapeutic; Therapeutic Clinical Trial; Time; Titrations; United States; abstracting; base; clinical practice; cost; cost effectiveness; economic outcome; evidence base; follow-up; health related quality of life; hemodynamics; high risk; improved; innovation; meetings; mortality; outcome forecast; prevent; prognostic; programs; response; treatment as usual; Accounting; Address; Adrenergic beta-Antagonists; Affect; American; Angiotensin-Converting Enzyme Inhibitors; Behavior; Biological Markers; Cardiovascular system; Cause of Death; Cessation of life; Chronic; Clinical; Clinical Treatment; Clinical Trials; Complex; Cost Control; Data; Data Coordinating Center; Disease Management; Dose; Economics; Guidelines; Heart failure; Hospitalization; Hospitals; Lead; Life; Long-Term Effects; Measurement; Medical; Meta-Analysis; Modeling; Morbidity - disease rate; Myocardium; NT-proBNP; National Heart, Lung, and Blood Institute; Natriuretic Peptides; Outcome; Patients; Performance; Physiological; Preventive; Provider; Public Health; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Resources; Strategic Planning; Stress; Systolic heart failure; Testing; Therapeutic; Therapeutic Clinical Trial; Time; Titrations; United States; abstracting; base; clinical practice; cost; cost effectiveness; economic outcome; evidence base; follow-up; health related quality of life; hemodynamics; high risk; improved; innovation; meetings; mortality; outcome forecast; prevent; prognostic; programs; response; treatment as usual

DESCRIPTION (provided by applicant): Heart failure (HF) is a major public health problem in the United States. Although medical therapy can improve outcomes, data suggest that proven therapies continue to be underutilized. Current guidelines suggest that treatment be titrated toward the target doses used in clinical trials, but "clinical inertia" often represents a barrier to aggressive titration of medical therap for both providers and patients. There is a pressing need to develop strategies to improve the utilization of proven therapies for chronic HF in order to improve outcomes. The natriuretic peptides are biomarkers of hemodynamic stress that provide important prognostic information in HF. Changes in natriuretic peptide levels over time are strongly associated with outcomes, and HF therapies proven to have beneficial effects outcomes decrease natriuretic peptide levels over time. These data suggest that serial measurements of natriuretic peptides may serve as a guide to the titration of medical therapy in HF - "biomarker guided therapy." Although small studies meta-analyses have suggested a decrease in mortality with this approach, there remains an unmet need for a robustly powered study to determine whether biomarker guided therapy improves outcomes in chronic HF. We propose to address this unmet need with the GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT) Study, a randomized clinical trial of biomarker guided therapy in HF. The primary aim of GUIDE-IT is to compare a strategy of medical therapy titrated to a natriuretic peptide target to usual care in 1100 high risk patients with HF. Our primary hypothesis is that biomarker guided therapy will reduce the composite endpoint of time to cardiovascular death or first HF hospitalization by 20% compared to usual care over a follow up period of at least 12 months. This application includes a Clinical Coordinating Center, a Data Coordinating Center, and an Economics-Quality of Life core lab. GUIDE-IT will test an innovative model of HF management-the individualized titration of medical therapy to a physiologic target rather than a "one size fits all" approach. Results of GUIDE-IT will be guideline changing and have immediate clinical implications for the management of millions of Americans living with chronic HF.

描述（由申请人提供）： 心力衰竭（HF）是美国的主要公共卫生问题。尽管医疗疗法可以改善结果，但数据表明，经过验证的疗法仍未得到充分利用。当前的指南表明，将治疗滴定针对临床试验中使用的靶剂量，但“临床惯性”通常代表了提供者和患者对医疗疗法进行积极滴定的障碍。迫切需要制定策略，以改善慢性HF的验证疗法以改善结果。亚钠肽是血液动力学胁迫的生物标志物，可在HF中提供重要的预后信息。随着时间的推移，亚位尿肽水平的变化与结局密切相关，而HF疗法被证明具有有益的效果结果会随着时间的推移降低亚位酸肽水平。这些数据表明，亚钠肽的系列测量可以作为HF中医疗疗法滴定的指南 - “生物标志物指导疗法”。尽管小型研究荟萃分析表明，这种方法的死亡率降低了，但仍需进行强有力的研究以确定生物标志物引导的治疗是否可以改善慢性HF的结果。我们建议使用生物标志物加强治疗（Guide-IT）研究（指导性证据疗法）研究（Guide-IT）研究，这是HF中生物标志物指导疗法的随机临床试验。指导的主要目的是将滴定到纳二肽肽靶靶的药物治疗策略与1100名HF患者的常规护理进行比较。我们的主要假设是，与在至少12个月的随访期内相比，与常规护理相比，生物标志物指导疗法将减少心血管死亡或第一次HF住院的综合时间终点。该应用程序包括一个临床协调中心，数据协调中心以及Life Core核心实验室的经济学质量。指南 - 它将测试HF管理的创新模型 - 对生理靶标的医疗疗法的个性化滴定，而不是“一种尺寸适合所有”方法。指南的结果将是指南的改变，并对数百万慢性HF的美国人的管理具有直接的临床意义。