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PERSEVERE-PEF: optimizing medical therapy saves lives in heart failure with preserved ejection fraction

PERSEVERE-PEF：优化药物治疗可挽救射血分数保留的心力衰竭患者的生命

基本信息

批准号：
10381898
负责人：
Gabriela Voskerician
金额：
$ 103.49万
依托单位：
OPTIMA INTEGRATED HEALTH, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-06-15 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10381898
关键词：
Address Affect Algorithms American Area Atrial Fibrillation Automobile Driving California Cardiology Caring Cessation of life Clinical Complex Confidential Information Consumption Coronary Arteriosclerosis Data Element Development Diagnosis Disease Disease Management Dissemination and Implementation EFRAC Electronic Health Record Environment Evidence based intervention Expert Systems Guidelines Health Personnel Health system Heart failure Home Hospitalization Hospitals Hypertension Incidence Individual Intelligence Judgment Left Liquid substance Logic Medical Methodist Church Monitor Patients Pharmacology Population Process Protocols documentation Randomized Recommendation Records Sampling San Francisco Services Site Software Validation Standardization Syndrome Testing Time Treatment Efficacy Universities Visualization Voting Work adjudicate care coordination clinical care clinical research site cohort college community clinic comorbidity cost data cleaning digital experience health data hospitalization rates hypertension control improved improved outcome interoperability meetings mortality personalized care post-COVID-19 preservation regression algorithm response system architecture treatment optimization volume hypertension

项目摘要

Need. In the US, heart failure (HF) is the contributing cause of 1 in 8 deaths. HF with preserved ejection fraction (HFpEF) affects close to 50% of all HF patients. The 5-years mortality is 35%. HFpEF multi-organ syndrome clinical care management is complex and time consuming. In addressing HFpEF, the American College of Cardiology guidelines directed medical therapy (GDMT) references the medical therapy decision to the individual disease guidelines [hypertension (HTN), coronary artery disease (CAD), atrial fibrillation (AFib)]. Providing concerted multi-disease HFpEF management is a major unmet clinical need. Solution. In response to this need, we (OPTIMA) developed and demonstrated the feasibility of a clinical analytic intelligence (AI) for the management of HFpEF multi-organ syndrome, optima4PEF AI. The solution adds significant value to OPTIMA’s HF Management Service currently addressing the GDMT management of HTN (optima4BP AI) and HFrEF (optima4heart AI). optima4PEF deconstructs a complex set of disease- specific clinical guidelines and re-assembles them into a concerted multi-disease GDMT that is patient- personalized, explainable, and actionable. Objectives. PERSEVERE-PEF [optimizing medical therapy saves lives in heart failure with preserved ejection fraction] proposes to complete the AI development of optima4PEF product concept, and to validate its efficacy using contemporary, diverse, retrospective patient cohorts. Aim 1. Build optima4PEF AI to address the GDMT management of HFpEF multi-organ syndrome. Hypothesis. optima4PEF deconstructs a complex set of disease-specific clinical guidelines and re-assembles them into a concerted multi-disease GDMT that is patient-personalized, explainable, and actionable. The product concept work built the optima4PEF AI system architecture and developed the decision logic to address GDMT management for patients experiencing HFpEF + volume overload + HTN. optima4PEF product concept will be extended to include GDMT management of AFib and of CAD. An end-to-end algorithm regression test will be performed to verify that each decision logic step performs its intended function. Aim 2. Validate optima4PEF AI in recommending the most relevant GDMT. Hypothesis. In ≥ 90% of patient cases, optima4PEF case-specific treatment recommendation is ACCEPTED as the appropriate next step in the process of multi-disease GDMT treatment optimization of patients diagnosed with HFpEF. Unidentified patient records will be collected from 4 clinical partner sites. A randomization algorithm will select n=840 patient records. optima4PEF will generate a Treatment Action (TA) for each patient record. A simple majority rule of pharmacology and cardiology experts (n=5) will adjudicate the optima4PEF TA. optima4PEF averts loss of lives by assisting in the delivery of HFpEF multi-disease management. optima4PEF surveillance & personalized care support the emerging digital-first clinical care practices.

需要的在美国，心力衰竭（HF）是八分之一死亡的原因。射血功能保留的HF HF部分（HFpEF）影响接近50%的所有HF患者。5年死亡率为35%。HFpEF多器官综合征临床护理管理复杂且耗时。在谈到HFpEF时，美国人心脏病学院指南指导的药物治疗（GDMT）将药物治疗决策引用为个体疾病指南[高血压（HTN）、冠状动脉疾病（CAD）、房颤（AFib）]。提供协调的多疾病HFpEF管理是一个主要的未满足的临床需求。溶液为了满足这一需求，我们（OPTIMA）开发并证明了临床用于HFpEF多器官综合征管理的分析智能（AI），Optima 4PEF AI。溶液为OPTIMA的HF管理服务增加了重要价值，目前该服务解决了以下GDMT管理问题： HTN（Optima4BP AI）和HFrEF（Optima4heart AI）。optima 4PEF解构了一系列复杂的疾病- 具体的临床指南，并重新组装成一个协调的多疾病GDMT，是病人- 个性化、可解释、可操作。目标. PERSEVERE-PEF [优化药物治疗可挽救射血功能保留的心力衰竭患者的生命 fraction]建议完成optima 4PEF产品概念的AI开发，并验证其有效性使用当代的、多样化的、回顾性的患者队列。目标1.构建optima 4PEF AI以解决HFpEF多器官综合征的GDMT管理。假说. optima 4PEF解构了一套复杂的疾病特异性临床指南，将它们转化为协调一致的多疾病GDMT，该GDMT是患者个性化的，可解释的和可操作的。产品概念工作构建了optima 4PEF AI系统架构，并开发了决策逻辑，解决HFpEF +容量超负荷+ HTN患者的GDMT管理。optima 4PEF产品概念将扩展到包括AFib和CAD的GDMT管理。一种端到端算法将执行回归测试，以验证每个决策逻辑步骤执行其预期功能。目标2. Approximoptima 4PEF AI推荐最相关的GDMT。假说.在≥ 90%的患者病例，optima 4PEF病例特定治疗建议被接受为适当的下一步 HFpEF患者多疾病GDMT治疗优化过程中的一步。将从4个临床合作研究中心收集未识别的患者记录。随机化算法将选择 n=840例患者记录。optima 4PEF将为每个患者记录生成治疗措施（TA）。一个简单药理学和心脏病学专家（n=5）的多数决原则将裁定optima 4PEF TA。 optima 4PEF通过协助提供HFpEF多疾病管理来避免生命损失。 optima 4PEF监测和个性化护理支持新兴的数字优先临床护理实践。