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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.

所需要的。在美国，每8例死亡中就有1例是心力衰竭（HF）造成的。HF与保留弹射