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

• 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
• 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

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。在美国，心力衰竭(HF)是导致八分之一死亡的原因。保留射血功能的HF 分数(HFpEF)影响近50%的心衰患者。5年死亡率为35%。HFpEF多脏器 证候临床护理管理复杂、耗时长。在向HFpEF发表讲话时，美国人 心脏病学会指导医疗指南(GDMT)将医疗决定引用到 个体化疾病指南[高血压(HTN)、冠心病(CAD)、房颤(AFib)]。 提供协调一致的多病种HFpEF治疗是一个尚未满足的主要临床需求。 解决办法。为了响应这一需求，我们(Optima)开发并展示了临床应用的可行性。 分析智能(AI)用于HFpEF多器官综合征的治疗，optima4PEF AI。解决方案 为Optima的高频管理服务增加了重大价值，目前正在解决GDMT管理的问题 HTN(Optima4BP AI)和HFrEF(optima4心AI)。Optima4PEF解构了一组复杂的疾病- 具体的临床指南，并将它们重新组装成一个协调一致的多疾病GDMT，这是患者- 个性化、可解释和可操作。 目标。Perevere-PEF[优化药物治疗以保存射血挽救心力衰竭患者的生命 FRAME]建议完成optima4PEF产品概念的人工智能开发，并验证其有效性 使用当代的、多样化的、有追溯性的患者队列。 目的1.建立optima4PEF人工智能，以解决GDMT对HFpEF多器官综合征的处理。 假设。Optima4PEF解构了一套复杂的针对疾病的临床指南，并重新组装 将它们整合成患者个性化、可解释和可操作的协调一致的多疾病GDMT。 产品概念工作构建了optima4PEF AI系统架构，并开发了决策逻辑以 为经历HFpEF+容量过载+HTN的患者提供GDMT管理。Optima4PEF产品 概念将扩展到包括AFib和CAD的GDMT管理。一种端到端的算法 将执行回归测试，以验证每个决策逻辑步骤是否执行其预期功能。 目的2.验证optima4PEF AI在推荐最相关的GDMT中的有效性。假设。在≥中，90%的 患者病例，optima4PEF针对具体病例的治疗建议被接受为合适的下一步 在多疾病GDMT治疗过程中优化诊断为HFpEF的患者。 不明身份的患者记录将从4个临床合作伙伴网站收集。随机化算法将选择 N=840份病历。Optima4PEF将为每个患者记录生成一个治疗操作(TA)。一个简单的 药理学和心脏病学专家(n=5)的多数规则将对optima4PEF TA进行裁决。 Optima4PEF通过协助提供HFpEF多疾病管理来避免生命损失。 Optima4PEF监控和个性化护理支持新兴的数字优先临床护理实践。