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：
10364460
负责人：
MANJULA KURELLA TAMURA
金额：
$ 68.39万
依托单位：
PALO ALTO VETERANS INSTIT FOR RESEARCH
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：
https://reporter.nih.gov/project-details/10364460
关键词：
Adult Affect African American Attenuated Benefits and Risks Blood Pressure California Cardiovascular system Cessation of life Chronic Kidney Failure Clinical Clinical Trials Consensus Data Databases Decision Making Diabetes Mellitus Disease Management Disease Progression Elderly Electronic Health Record Event Goals Guidelines Healthcare Systems Hypertension Individual Intervention Trial Kidney Kidney Diseases Laboratories Lead Modeling Participant Patients Persons Pharmaceutical Preparations Pharmacy facility Population Recommendation Renal function Research Priority Risk Secondary Prevention Serious Adverse Event Stroke Subgroup Target Populations Uncertainty Veterans Health Administration blood pressure intervention blood pressure medication cardiovascular risk factor clinical decision support cohort comparative high risk population hypertension control hypertension treatment innovation mortality mortality risk novel patient population personalized predictions profiles in patients randomized trial symposium treatment 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.

项目概要/摘要高血压影响超过 80% 的慢性肾病 (CKD) 成年人，其治疗方法是 CKD 管理的基石。临床指南对血压目标的建议各不相同 CKD，反映了收缩压干预试验 (SPRINT) 解释中的不确定性及其外推至患有 CKD 的成人，尤其是患有晚期 CKD 的成人。尽管证据来自随机试验具有很强的内部效度，但它可能无法反映患者群体的风险收益状况将在实践中接受治疗。我们的首要目标是评估比较风险和收益现实世界中患有 CKD 的成年人的强化血压目标与标准血压目标。我们的次要目标是证明新颖的分析方法的可行性和实用性，这些方法可以扩展因果效应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来自两个大型医疗保健系统（涵盖 1300 万参保者）的数据 - 退伍军人健康局南加州政府和凯撒医疗机构。为了告知我们现实世界的估计，我们将整合来自 20,000 名参与者的四项不同高血压试验的个人数据。在目标 1 中，我们将估计符合 SPRINT 资格的强化血压目标与标准血压目标的平均治疗效果现实世界中患有 CKD 的成年人。在目标 2 中，我们将开发并验证个性化预测模型强化血压治疗效果，并说明其在现实世界 CKD 人群中的应用。瞄准 3、我们将使用电子健康模拟血压药物强化的序贯临床试验慢性肾病患者的记录。我们的研究很重要，因为高血压治疗几乎影响所有成年人慢性肾病（CKD）和关键证据差距可能会导致这一高危人群的管理不理想。这是创新，因为它将提供关于强化血压目标的影响的新证据，利用真实世界数据支持临床决策的新分析方法。