TRANSFORM-HF DCC
变换-HF DCC
基本信息
- 批准号:9310535
- 负责人:
- 金额:$ 84.25万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-08-15 至 2022-07-31
- 项目状态:已结题
- 来源:
- 关键词:AcuteAddressAmericanAmerican Heart AssociationAncillary StudyApplications GrantsBeliefBiomedical ResearchCardiologyCardiovascular systemCaringClinicalClinical ResearchClinical TrialsClinical Trials Data Monitoring CommitteesClinical effectivenessCollaborationsCompanionsComplementCongestiveDataData CollectionData Coordinating CenterData ElementData QualityDevelopmentDiureticsDoctor of PhilosophyEconomic BurdenEnrollmentEnvironmentEquipoiseFormulationFosteringFurosemideFutureGeneric DrugsGuidelinesHeart failureHospitalizationHospitalsLeadershipLiquid substanceMissionMonitorMonitoring Clinical TrialsMorbidity - disease rateNational Heart, Lung, and Blood InstituteOralOrganization and AdministrationOutcomePatientsPharmacodynamicsPhasePhase III Clinical TrialsPopulationPragmatic clinical trialProceduresProductivityProtocols documentationRandomizedRecruitment ActivityResearchResearch InstituteResearch PersonnelRiskSiteStatistical Data InterpretationSymptomsTestingTimeTreatment FailureUnited StatesValidationVital StatusWomanagedarmbaseclinical practicecollegecomparative effectivenesscostdata acquisitiondata integrationdata managementdesigndissemination researchethnic minority populationexperienceflexibilityfollow-uphealth related quality of lifeimprovedimproved outcomeinnovationmedication compliancemortalityoperationpaymentprogramsprospectiveprototyperacial minoritytooltreatment durationtreatment effecttreatment strategy
项目摘要
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 DCC application.
心力衰竭(HF)是65岁或以上患者住院的最常见原因,
给美国人民带来巨大的个人、社会和经济负担。髓袢利尿剂,如
托拉塞米和呋塞米是用于改善充血症状的HF治疗的基础。之前
数据表明,与呋塞米相比,托拉塞米有利地改变了病理生理机制,
与疾病进展相关,具有良好的药效学特征,可降低HF发病率,
mortality.然而,呋塞米在日常实践中被压倒性地使用,这突出了临床平衡和
一项充分把握度研究的未满足需求,以明确确定托拉塞米与
呋塞米改善预后以指导临床实践。托拉塞米与呋塞米的比较
FOR HF管理(TRANSFORM-HF)试验是一项具有强大把握度的前瞻性随机试验,
比较有效性研究,这将改变指导方针,并立即临床
这对数百万HF患者的管理具有重要意义。的主要假设
TRANSFORM-HF试验表明,与对照组相比,
在12个月的时间里服用呋塞米。重要的次要假设包括,与
呋塞米将1)降低1年全因死亡率和首次HF再住院率; 2)改善健康相关
生活质量;和3)与对照组相比,
呋塞米。TRANSFORM-HF临床协调中心(CCC)的具体目标和数据
协调中心(DCC)的职责是(1)建立和管理临床试验组织,
协调研究的进行和分析;(2)实施和监测一个“现实世界”,大规模,务实,
临床有效性研究,使用简化的数据采集和呼叫中心随访,以及(3)传播
试验结果和影响,以广泛的受众,并作为一个原型,为未来的务实临床
审判我们在6,000例住院HF患者中进行的前瞻性、非盲、2组、III期临床试验,
少数民族和女性的稳健入组将受试者1:1随机分配至口服
Torsemide或速尿出院前。入组将在50家已确诊HF的美国医院研究中心进行
临床卓越系统的数据采集方法将最大限度地减少研究者和受试者的负担,
在6个月和12个月时使用呼叫中心记录生命状态、药物依从性和健康相关质量
并获取住院信息。TRANSFORM-HF试验将由研究者和一名
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高度成熟的环境中工作。这
申请是作为两个集群R 01赠款建议提交的,其中详细说明了CCC(PI博士。Velazquez)和
DCC(PIs-Anstrom和Eisenstein博士)。本提案提出了DCC应用。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kevin J Anstrom其他文献
Extended Thromboprophylaxis in Patients Hospitalized with COVID-19 at Time of Discharge from the Hospital Is Not Associated with an Improvement in Quality of Life: Results from the Activ 4c Clinical Trial
- DOI:
10.1182/blood-2023-190552 - 发表时间:
2023-11-02 - 期刊:
- 影响因子:
- 作者:
Lisa Baumann Kreuziger;Taeim Kwon;Lana Wahid;Raj S. Kasthuri;Andrei L. Kindzelski;M. Margaret Knudson;Jerry Krishnan;Gervasio Lamas;Eric Leifere;Jose Lopez-Sendon;Peter J Miller;Bela Patel;Alexandra J Weissman;John Quigley;Deborah Siegal;Tracy Y Wang;Kevin J Anstrom;Thomas L. Ortel - 通讯作者:
Thomas L. Ortel
1123-180 Incidence and evaluation of heparin-induced thrombocytopenia (HIT) among patients treated with prolonged heparin and among thrombocytopenic patients in the cardiac care unit: Preliminary results of the CATCH registry
- DOI:
10.1016/s0735-1097(04)92119-5 - 发表时间:
2004-03-03 - 期刊:
- 影响因子:
- 作者:
Eric M Crespo;Richard C Becker;Peter B Berger;Christopher B Granger;Neal S Kleinman;David J Moliterno;Stephan Moll;Lawrence Rice;Charles S Abrams;JoEllen Rogers;Stephen S Steinhubl;Victor F Tapson;Kevin J Anstrom;E.Magnus Ohman - 通讯作者:
E.Magnus Ohman
Kevin J Anstrom的其他文献
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{{ truncateString('Kevin J Anstrom', 18)}}的其他基金
Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center
背痛联盟 (BACPAC) 研究计划数据集成、算法开发和运营管理中心
- 批准号:
10400459 - 财政年份:2019
- 资助金额:
$ 84.25万 - 项目类别:
Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center
背痛联盟 (BACPAC) 研究计划数据集成、算法开发和运营管理中心
- 批准号:
10396871 - 财政年份:2019
- 资助金额:
$ 84.25万 - 项目类别:
Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center
背痛联盟 (BACPAC) 研究项目数据集成、算法开发和运营管理中心
- 批准号:
9898044 - 财政年份:2019
- 资助金额:
$ 84.25万 - 项目类别:
Trial to Assess Chelation Therapy 2 (TACT2) DCC
评估螯合疗法 2 (TACT2) DCC 的试验
- 批准号:
9182074 - 财政年份:2015
- 资助金额:
$ 84.25万 - 项目类别:
Trial to Assess Chelation Therapy 2 (TACT2) DCC
评估螯合疗法 2 (TACT2) DCC 的试验
- 批准号:
9144715 - 财政年份:2015
- 资助金额:
$ 84.25万 - 项目类别:
Trial to Assess Chelation Therapy 2 (TACT2) DCC Supplemental Bridge Funding
评估螯合疗法 2 (TACT2) DCC 补充过渡资金的试验
- 批准号:
10393120 - 财政年份:2015
- 资助金额:
$ 84.25万 - 项目类别:
Study of Co-trimoxazole and Proton Pump Inhibition Using Pragmatic Design in Idiopathic Pulmonary Fibrosis - CleanUP-IPF
使用实用设计研究复方新诺明和质子泵抑制治疗特发性肺纤维化 - CleanUP-IPF
- 批准号:
8956219 - 财政年份:2015
- 资助金额:
$ 84.25万 - 项目类别:
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