TRANSFORM-HF CCC

变换-HF CCC

• 批准号: 9309940
• 负责人: Eric J Velazquez
• 金额: $ 163.66万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-15 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9309940
• 关键词: Accounting; Adult; Affect; Aldosterone; American; American Heart Association; Ancillary Study; Applications Grants; Biological Availability; Cardiac; Cardiology; Cardiovascular system; Caring; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical effectiveness; Communication; Companions; Congestive; Conscious; Data; Data Coordinating Center; Diuretics; Doctor of Philosophy; Economic Burden; Edema; Education; Enrollment; Ensure; Environment; Equipoise; Ethics; Formulation; Fostering; Furosemide; Future; Gender; Generic Drugs; Guidelines; Half-Life; Health; Healthcare Systems; Heart failure; Hospitalization; Hospitals; Intake; Lead; Leadership; Liquid substance; Meta-Analysis; Monitor; Morbidity - disease rate; Natriuretic Peptides; Nurse Practitioners; Nurses; Oral; Organization and Administration; Outcome; Patient Care; Patient-Focused Outcomes; Patients; Pattern; Penetrance; Peripheral; Pharmacists; Pharmacodynamics; Phase III Clinical Trials; Physicians; Population; Pragmatic clinical trial; Prevalence; Principal Investigator; Procedures; Production; Protocols documentation; Provider; Public Health; Publications; Randomized; Renin-Angiotensin-Aldosterone System; Research; Research Infrastructure; Research Institute; Research Personnel; Shortness of Breath; Site; Sodium; Sympathetic Nervous System; Symptoms; Testing; Time; TimeLine; Treatment Failure; United States; Ventricular Remodeling; Vital Status; Water; Woman; absorption; aged; aging population; arm; clinical practice; college; comparative effectiveness; coronary fibrosis; cost; data acquisition; data integration; data management; dissemination research; ethnic minority population; experience; follow-up; health related quality of life; improved; improved outcome; innovation; medication compliance; mortality; operation; pre-clinical; programs; prospective; prototype; racial and ethnic; racial minority; screening; symposium; vasoconstriction; web site

Heart Failure (HF) is the most frequent cause of hospitalization among patients aged 65 or greater and leads to an enormous personal, societal and economic burden for the US population. Loop diuretics such as torsemide and furosemide are a cornerstone of HF therapy utilized to improve congestive symptoms. Prior data suggest that torsemide compared to furosemide advantageously alters pathophysiological mechanisms associated with progression, has a favorable pharmacodynamic profile and may decrease HF morbidity and mortality. Yet, furosemide is overwhelmingly utilized in daily practice which highlights clinical equipoise and an unmet need for an adequately powered study to definitively determine whether torsemide compared to furosemide improves outcomes to guide clinical practice. The ToRsemide compArisoN with furoSemide FOR Management of HF (TRANSFORM-HF) trial is a robustly-powered, prospective, randomized, comparative-effectiveness study which will change guidelines and have immediate clinical implications for the management of millions of patients with HF. The primary hypothesis of the TRANSFORM-HF trial is that torsemide will reduce all-cause mortality by a relative 15% compared with furosemide over a period of 12 months. Important secondary hypotheses include that torsemide compared to furosemide will 1) reduce 1-year all-cause mortality and first HF re-hospitalization; 2) improve health-related quality of life; and 3) increase survival time and decrease total cardiovascular hospitalizations compared with furosemide. The specific aims of the TRANSFORM-HF Clinical Coordinating Center (CCC) and Data Coordinating Center (DCC) are to (1) Develop and administrate a clinical trial organization to efficiently coordinate study conduct and analysis; (2) Implement and monitor a “real-world”, large-scale, pragmatic, clinical-effectiveness study using streamlined data acquisition with call center follow-up, and (3) Disseminate the trial results and implications to a broad audience and serve as a prototype for future pragmatic clinical trials. Our prospective, unblinded, 2-arm, phase III clinical trial of 6,000 hospitalized HF patients targeting robust enrollment of racial and ethnic minorities and women will randomize subjects 1:1 to either oral torsemide or furosemide prior to discharge. Enrollment will occur at 50 US hospital sites with established HF clinical excellence. A systematic data acquisition approach will minimize investigator and subject burden and use a call center at 6 and 12 months to document vital status, medication adherence, and health-related quality of life, and to acquire hospitalization information. The TRANSFORM-HF trial will be led by investigators and an operations team with substantial experience and expertise in HF care, clinical trials, data integration and administration working within the highly proven environment of the Duke Clinical Research Institute. This application is submitted as two clustered R01 grant proposals which detail a CCC (PI-Dr. Velazquez) and a DCC (PIs-Drs. Anstrom and Eisenstein). This proposal presents the CCC application.

心力衰竭（HF）是65岁或更高的患者中最常住院的原因 给美国人口带来巨大的个人，社会和经济负担。循环利尿剂，例如 扭转和速尿是用于改善充血符号的HF疗法的基石。事先的 数据表明，与速尿相比，扭转有利地改变了病理生理机制 与进展相关，具有良好的药效学特征，可能会降低HF的发病率和 死亡。然而，在日常练习中，速食剂是绝大多数的，这突出了临床平衡和 对足够动力的研究未满足，以明确确定托西利是否与 速尿改善了指导临床实践的结果。与速尿的扭转比较 对于HF（变换-HF）试验的管理是一个强大的，前瞻性的，随机的， 比较效率研究将改变准则并立即具有临床 对数百万HF患者的管理的影响。主要假设 转化-HF试验是，与 在12个月内的速尿。重要的次要假设包括与 速尿将1）降低1年全因死亡率和第一次HF重新住院； 2）改善与健康有关的 生活质量； 3）增加生存时间并减少总体心血管住院治疗 速尿。 Transform-HF临床协调中心（CCC）和数据的具体目的 协调中心（DCC）将（1）开发和管理员一个临床试验组织，以有效 协调研究的行为和分析； （2）实施并监视“现实世界”，大规模，务实， 临床效率研究使用呼叫中心随访的简化数据采集，（3）传播 试验结果和对广泛受众的影响，并作为未来务实临床的原型 试验。我们对6,000名住院的HF患者的前瞻性，无盲，2臂的III期临床试验 种族和少数族裔和妇女的强大入学人数将使受试者随机将1：1随机纳入任何口头 出院前的扭转或速尿。入学率将在美国50个医院现场发生 临床卓越。系统的数据获取方法将使研究人员和受试者烧伤最小 使用6个月和12个月的呼叫中心记录重要状态，药物依从性和与健康相关的质量 生活，并获得住院信息。 Transform-HF试验将由调查人员和 具有丰富经验和专业知识的运营团队，在HF护理，临床试验，数据集成和 在杜克临床研究所的著名环境中工作的管理。这 申请被提交为两个聚集的R01赠款提案，详细介绍了CCC（Pi-Dr。Velazquez）和A DCC（Pis-Drs。Anstrom和Eisenstein）。该提案介绍了CCC申请。