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: 10444784
• 负责人: Ambarish Pandey
• 金额: $ 75.11万
• 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/10444784
• 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; Enrollment; Failure; Formulation; Glucose; Guidelines; Health; Health Insurance; Heart failure; Hospitalization; Hospitals; Individual; LDL Cholesterol Lipoproteins; Lead; 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; base; 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.

项目摘要/摘要 心力衰竭在美国构成了一个重大的公共卫生挑战，尤其是越来越多的患病率 在社会经济地位低下的非白人个人和个人中。不断扩大的数量 已显示药物可改善心力衰竭患者的生存率，射血分数降低 （HFREF）。指导指导的医疗疗法清单（GDMT）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 - 涅prilysin抑制剂，以及 矿物皮质激素受体拮抗剂。当组合使用时，这些药物减少了全因素 死亡率> 50％。尽管如此，在 任何剂量，低SES个体的利用率尤其低。 Polypill是指单一药物中的固定剂量组合，旨在减轻药丸负担和 改善依从性。 Polypill策略提供了一种可以使用多种药物治疗的手段 便利地在疾病的早期阶段开始，随着时间的推移增加了总体治疗益处。 这在患者由于高成本而经常经常出现护理障碍的环境中尤其重要 实验室测试，需要多次后续访问。 我们提出了一项基于polypill的策略的单中心，务实的试验，用于在低 - 中治疗HFREF 收入，种族多样性人口。我们将注册175名患有HFREF的成年人（左心室射血分数 [LVEF] <40％）在不使用最佳目标剂量指导的帕克兰医院接受护理 德克萨斯州达拉斯的大县医院的医疗疗法。参与者将被随机接收息肉 或通常的护理。研究的主要终点是LVEF的变化，关键的次要结果将是 循环NT-Probnp水平，寿命，步行六分钟的距离以及遵守的变化 指南指示医疗治疗12个月。我们假设在使用基于polypill的策略 HFREF将是可行的，并导致左心室收缩功能的改善，NT-Probnp水平，生活质量， 与通常的护理相比，遵守剂量指南指示药物治疗。