Polypill strategy for the evidence-based management of heart failure with reduced ejection fraction in an underserved patient population

在服务不足的患者群体中对射血分数降低的心力衰竭进行循证管理的多药丸策略

• 批准号: 10622331
• 负责人: Ambarish Pandey
• 金额: $ 71.78万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-14 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10622331
• 关键词: Address; Adherence; Adoption; Adrenergic beta-Antagonists; Adult; Angiotensin Receptor; Angiotensin-Converting Enzyme Inhibitors; Blood Pressure; Cardiovascular system; Caring; Clinical; Combination Medication; Communities; Conduct Clinical Trials; County Hospitals; Disease; Dose; EFRAC; Effectiveness; Elderly; Eligibility Determination; Enrollment; Formulation; Glucose; Guidelines; Health; Health Insurance; Heart failure; Hospitalization; Hospitals; Individual; LDL Cholesterol Lipoproteins; Left; Left Ventricular Ejection Fraction; Low Income Population; Low income; Medicaid; Medical; Metoprolol Succinate; Mineralocorticoid Receptor; Morbidity - disease rate; Neprilysin; Outcome; Participant; Patient Care; Patients; Pharmaceutical Preparations; Population; Population Heterogeneity; Prevalence; Primary Prevention; Provider; Public Health; Quality of life; Randomized; Regimen; Registries; Renin-Angiotensin System; Reproducibility; Risk Factors; Secondary Prevention; Sodium; Spironolactone; System; Testing; Texas; Therapeutic; Time; Titrations; Treatment Failure; Underinsured; Uninsured; United States; Ventricular; Visit; Walking; antagonist; barrier to care; cardiac magnetic resonance imaging; cardiovascular disorder prevention; cost; effective therapy; evidence base; experience; feasibility testing; follow-up; heart imaging; imaging modality; improved; inhibitor; low socioeconomic status; medication compliance; mortality; patient population; pill; pragmatic trial; primary endpoint; pro-brain natriuretic peptide (1-76); racial disparity; racial diversity; randomized trial; secondary outcome; socioeconomic disparity; treatment as usual; treatment strategy; uptake

Project Summary/Abstract Heart failure poses a major public health challenge in the United States, with growing prevalence particularly among non-white individuals and individuals of low socioeconomic status (SES). An expanding number of medications have been shown to improve survival in patients with heart failure with reduced ejection fraction (HFrEF). The list of guideline-directed medical therapies (GDMT) includes beta-blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, and mineralocorticoid receptor antagonists. When used in combination, these medications reduce all-cause mortality by > 50%. Nonetheless, fewer than 25% of eligible patients receive 3 or more of these medications, at any dose, with particularly low rates of utilization among low SES individuals. The polypill refers to a fixed-dose combination of medications in a single pill, aimed at reducing pill burden and improving adherence. The polypill strategy offers a means by which therapy with multiple medications can be conveniently initiated at an early stage of disease, increasing the overall therapeutic benefit accrued over time. This is particularly relevant in settings where patients experience barriers to care due to high costs, frequent lab tests, and need for multiple follow up visits. We propose a single-center, pragmatic trial of a polypill-based strategy for the treatment of HFrEF in a low- income, racially-diverse population. We will enroll 175 adults with HFrEF (left ventricular ejection fraction [LVEF] < 40%) receiving care at Parkland Hospital who are not on optimal, target dose of guideline-directed medical therapy at a large county hospital in Dallas, TX. Participants will be randomized to receiving a polypill or usual care. The primary endpoint of the study is the change in LVEF, and the key secondary outcome will be change in circulating NT-proBNP levels, quality-of-life, six minute walk distance, and the adherence to guideline directed medical therapy at 12 months. We hypothesize that use of a polypill-based strategy in HFrEF will be feasible and lead to improved left ventricular systolic function, NT-proBNP levels, quality of life, and adherence to target dose guideline directed medical therapy compared with usual care.

项目概要/摘要 心力衰竭在美国构成了重大的公共卫生挑战，尤其是患病率不断上升 非白人和社会经济地位较低（SES）的个人。数量不断增加 药物已被证明可以提高射血分数降低的心力衰竭患者的生存率 （HFrEF）。指南指导的药物治疗 (GDMT) 清单包括 β 受体阻滞剂、血管紧张素 转化酶抑制剂、血管紧张素受体阻滞剂、血管紧张素受体脑啡肽酶抑制剂，以及 盐皮质激素受体拮抗剂。当联合使用时，这些药物可减少全因 死亡率> 50%。尽管如此，只有不到 25% 的符合条件的患者接受了 3 种或以上这些药物， 任何剂量，低社会经济地位个体的利用率特别低。 复方药是指单一药丸中固定剂量的药物组合，旨在减少药丸负担和 提高依从性。复方药丸策略提供了一种可以同时使用多种药物进行治疗的方法。 在疾病的早期阶段方便地启动，随着时间的推移增加总体治疗效果。 这在患者因高成本、频繁的护理而遇到护理障碍的环境中尤其重要。 实验室测试，并需要多次随访。 我们提出了一项基于多药丸策略的单中心、实用性试验，用于在低风险人群中治疗 HFrEF。 收入、种族多样化的人口。我们将招募 175 名患有 HFrEF（左心室射血分数 [LVEF] < 40%）在 Parkland 医院接受护理，未接受指南指导的最佳目标剂量 在德克萨斯州达拉斯市的一家大型县医院接受药物治疗。参与者将被随机分配接受复方药丸 或平时护理。该研究的主要终点是 LVEF 的变化，关键的次要结果是 循环 NT-proBNP 水平、生活质量、六分钟步行距离以及坚持的变化 12 个月时遵循指南指导的药物治疗。我们假设使用基于多药丸的策略 HFrEF 将是可行的，并能改善左心室收缩功能、NT-proBNP 水平、生活质量、 与常规护理相比，坚持目标剂量指南指导的药物治疗。