Applying Hypertension Clinical Trials to Real World Adults with CKD
将高血压临床试验应用于现实世界中患有 CKD 的成人
基本信息
- 批准号:10494235
- 负责人:
- 金额:$ 64.94万
- 依托单位:
- 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:2021-09-24 至 2026-05-31
- 项目状态:未结题
- 来源:
- 关键词:AdultAffectAfrican AmericanAttenuatedBenefits and RisksBlood PressureCaliforniaCardiovascular systemCessation of lifeChronic Kidney FailureClinicalClinical TrialsConsensusDataDatabasesDecision MakingDiabetes MellitusDisease ManagementDisease ProgressionElderlyElectronic Health RecordEventGoalsGuidelinesHealthcare SystemsHypertensionIndividualIntervention TrialKidneyKidney DiseasesLaboratoriesLeadModelingParticipantPatientsPersonsPharmaceutical PreparationsPharmacy facilityPopulationRecommendationRenal functionResearch PriorityRiskSecondary PreventionSerious Adverse EventStrokeSubgroupTarget PopulationsUncertaintyVeterans Health Administrationblood pressure interventionblood pressure medicationcardiovascular risk factorclinical decision supportcohortcomparativehigh risk populationhypertension controlhypertension treatmentinnovationmortalitymortality risknovelpatient populationpersonalized predictionsprofiles in patientsrandomized trialsymposiumtreatment effect
项目摘要
PROJECT SUMMARY / ABSTRACT
Hypertension affects more than 80% of adults with chronic kidney disease (CKD), and its treatment is a
cornerstone of CKD management. Clinical guidelines vary in their recommendations for blood pressure targets
in CKD, reflecting uncertainties in the interpretation of the Systolic Blood Pressure Intervention Trial (SPRINT)
and its extrapolation to adults with CKD, particularly those with advanced CKD. Although evidence from
randomized trials has strong internal validity, it may not reflect the risk benefit profile of patient populations that
will receive treatment in practice. Our overarching goal is to evaluate the comparative risks and benefits of
intensive versus standard blood pressure targets in real world adults with CKD. Our secondary goal is to
demonstrate the feasibility and utility of novel analytical approaches that extend causal effects from
randomized trial effects to broader populations. We will accomplish these goals by leveraging electronic health
record data from two large health care systems encompassing 13 million enrollees - the Veterans Health
Administration and Kaiser Permanente of Southern California. To inform our real-world estimates, we will
integrate individual-level data from four diverse hypertension trials on 20,000 participants. In Aim 1, we will
estimate average treatment effects of intensive versus standard blood pressure targets among SPRINT-eligible
real world adults with CKD. In Aim 2, we will develop and validate models for individualized prediction of
intensive blood pressure treatment effects, and illustrate the application in real world CKD populations. In Aim
3, we will emulate a sequential clinical trial of blood pressure medication intensification using electronic health
records in persons with CKD. Our study is important because hypertension treatment affects nearly all adults
with CKD and key evidence gaps may lead to suboptimal management in this high-risk population. It is
innovative because it will provide new evidence about the implications of intensive blood pressure targets and
new analytic approaches to support clinical decisions with real world data.
项目总结/摘要
高血压影响超过80%的慢性肾脏病(CKD)成人,其治疗是一种治疗方法。
CKD管理的基石。临床指南对血压目标的建议各不相同
在CKD中,反映了对收缩压干预试验(SPRINT)解释的不确定性
并将其外推至CKD成人患者,尤其是晚期CKD患者。虽然证据来自
随机试验具有很强的内部效度,它可能不能反映患者人群的风险受益特征,
在实践中接受治疗。我们的总体目标是评估以下方面的比较风险和收益:
在真实的CKD成人中强化与标准血压目标的比较。我们的第二个目标是
展示了新的分析方法的可行性和实用性,这些方法将因果效应从
随机试验对更广泛人群的影响。我们将通过利用电子健康来实现这些目标
记录数据来自两个大型医疗保健系统,包括1300万注册者-退伍军人健康
南加州的管理和凯撒永久。为了告知我们的真实世界估计,我们将
整合了来自4项不同高血压试验的20,000名参与者的个人水平数据。在目标1中,我们
在符合SPRINT条件的患者中,估计强化与标准血压目标的平均治疗效果
真实的成人CKD患者。在目标2中,我们将开发和验证用于个性化预测的模型,
强化血压治疗效果,并说明在真实的世界CKD人群中的应用。在Aim中
3、我们将效仿使用电子健康的血压药物强化的序贯临床试验
CKD患者的记录。我们的研究很重要,因为高血压治疗几乎影响所有成年人
CKD患者和关键证据缺口可能导致该高风险人群的管理不佳。是
创新,因为它将提供关于强化血压目标影响的新证据,
利用真实的世界数据支持临床决策的新分析方法。
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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MANJULA KURELLA TAMURA其他文献
MANJULA KURELLA TAMURA的其他文献
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{{ truncateString('MANJULA KURELLA TAMURA', 18)}}的其他基金
A Mentoring Program in Kidney Care for Older Adults
老年人肾脏护理指导计划
- 批准号:
10449851 - 财政年份:2022
- 资助金额:
$ 64.94万 - 项目类别:
A Mentoring Program in Kidney Care for Older Adults
老年人肾脏护理指导计划
- 批准号:
10656289 - 财政年份:2022
- 资助金额:
$ 64.94万 - 项目类别:
Applying Hypertension Clinical Trials to Real World Adults with CKD
将高血压临床试验应用于现实世界中患有 CKD 的成人
- 批准号:
10364460 - 财政年份:2021
- 资助金额:
$ 64.94万 - 项目类别:
Applying Hypertension Clinical Trials to Real World Adults with CKD
将高血压临床试验应用于现实世界中患有 CKD 的成人
- 批准号:
10666583 - 财政年份:2021
- 资助金额:
$ 64.94万 - 项目类别:
Developing Tools for Dialysis Decision Support in Older Adults
开发老年人透析决策支持工具
- 批准号:
10213136 - 财政年份:2020
- 资助金额:
$ 64.94万 - 项目类别:
Developing Tools for Dialysis Decision Support in Older Adults
开发老年人透析决策支持工具
- 批准号:
10735868 - 财政年份:2020
- 资助金额:
$ 64.94万 - 项目类别:
Developing Tools for Dialysis Decision Support in Older Adults
开发老年人透析决策支持工具
- 批准号:
10450652 - 财政年份:2020
- 资助金额:
$ 64.94万 - 项目类别:
Understanding the Initiation of Maintentenance Dialysis among Older Veterans
了解老年退伍军人维持透析的开始
- 批准号:
10181033 - 财政年份:2014
- 资助金额:
$ 64.94万 - 项目类别:
Understanding the Initiation of Maintentenance Dialysis among Older Veterans
了解老年退伍军人维持透析的开始
- 批准号:
8780220 - 财政年份:2014
- 资助金额:
$ 64.94万 - 项目类别:
Understanding the Initiation of Maintentenance Dialysis among Older Veterans
了解老年退伍军人维持透析的开始
- 批准号:
10178093 - 财政年份:2014
- 资助金额:
$ 64.94万 - 项目类别:
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