Management and Outcomes of Heart Failure with Preserved Systolic Function

保留收缩功能的心力衰竭的治疗和结果

• 批准号: 7934575
• 负责人: Alan S Go
• 金额: $ 49.99万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7934575
• 关键词: Address; Adrenergic beta-Antagonists; Adult; Adverse event; Affect; Age; Aldosterone Receptors; American; Angiotensin-Converting Enzyme Inhibitors; Area; Cardiovascular system; Caring; Cessation of life; Characteristics; Chronic; Chronic Kidney Failure; Clinical; Clinical Research; Collaborations; Coronary heart disease; Data; Devices; Diabetes Mellitus; Diagnosis; Diastolic heart failure; Digoxin; Diuretics; Effectiveness; Elderly; Epidemiology; Ethnic group; Evaluation; Event; Future; Health Planning; Heart failure; Hospitalization; Knowledge; Left; Left Ventricular Ejection Fraction; Mineralocorticoid Receptor; National Heart, Lung, and Blood Institute; Nitrates; Outcome; Patients; Pattern; Persons; Population; Population Heterogeneity; Public Health; Randomized Clinical Trials; Research; Resources; Risk; Safety; Subgroup; Syndrome; United States National Institutes of Health; Variant; Ventricular; adverse outcome; aged; base; cohort; improved; insight; member; outcome forecast; patient population; premature; racial and ethnic; randomized trial; sex; trend

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (04) Clinical Research and specific Challenge Topic, 04-HL- 105: Treatment of Heart Failure with Preserved Systolic Function Multiple advances in pharmacological and device therapies have been made to improve the care and outcomes for patients with heart failure and reduced left ventricular systolic function. However, the epidemiology of heart failure has been changing over the past several decades, with more than half of adults with clinically recognized heart failure syndromes currently having "preserved" left ventricular systolic function-typically defined as having a left ventricular ejection fraction of >50% or qualitative assessment of normal or preserved systolic function. Despite these changing trends and the expanding burden of heart failure, we have very few insights into any therapies that reduce the risk of premature death or heart failure exacerbation for patients with heart failure and preserved systolic function. Furthermore, we lack contemporary information on characteristics and event rates from diverse populations of patients who have heart failure with preserved systolic function that would help guide planning for future randomized clinical trials in these patients. To address these major knowledge gaps highlighted in NIH Challenge Topic 05-HL-105, we propose to leverage the National Heart, Lung and Blood Institute-sponsored Cardiovascular Research Network (CVRN), a multicenter, health plan-based research network that provides care for ~11 million members across the U.S. Through a collaboration of four participating CVRN centers, we propose to assemble a large, contemporary diverse cohort of adults with diagnosed heart failure and documented preserved left ventricular systolic function to examine the following three Specific Aims: Aim 1. To assemble a large, diverse multicenter cohort of adults with heart failure and documented preserved left ventricular systolic function between 2000-2008 and characterize recent practice patterns with available heart failure therapies. Aim 2. To determine contemporary rates and predictors of death, hospitalization for heart failure, and total resource utilization among adults with heart failure and preserved systolic function, overall and in targeted patient subgroups. Aim 3. Given the limited randomized clinical trial evidence in this population, to provide a preliminary evaluation of the effectiveness and safety of targeted therapies (i.e., ACE inhibitors, beta-blockers, and aldosterone receptor antagonists) that have been proven to be beneficial for patients with heart failure and reduced systolic function as well as exploring the outcomes associated with other commonly used therapies in chronic heart failure (e.g., diuretics, digoxin, nitrates, and statins). The public health burden for chronic heart failure is substantial-affecting 5.7 million Americans-the majority of whom are aged 65 years or older. More than half of patients with heart failure have preserved left ventricular systolic function, a condition whose prognosis remains poor and for which we have few randomized clinical trial data to guide therapy. The proposed study will provide critical and timely insights into contemporary adverse event rates and predictors of adverse outcomes, as well as into potential ways to improve the care and outcomes of the growing population of patients with heart failure and preserved systolic function.

描述（由申请人提供）：该申请涉及广泛的挑战领域（04）临床研究和特定的挑战主题，04- hl - 105：保留收缩功能的心力衰竭治疗药物和器械治疗已经取得了多项进展，以改善心力衰竭和左心室收缩功能降低患者的护理和结果。然而，在过去的几十年里，心力衰竭的流行病学已经发生了变化，目前超过一半的临床公认的心力衰竭综合征的成年人左心室收缩功能“保留”——通常定义为左心室射血分数为bbb50 %或定性评估为正常或保留的收缩功能。尽管这些变化的趋势和心力衰竭的负担不断扩大，但我们对任何治疗方法的见解都很少，这些治疗方法可以降低心力衰竭和保留收缩功能的患者过早死亡或心力衰竭加剧的风险。此外，我们缺乏关于保留收缩功能的心力衰竭患者不同人群的特征和事件发生率的当代信息，这将有助于指导这些患者未来随机临床试验的规划。为了解决NIH挑战主题05-HL-105中强调的这些主要知识差距，我们建议利用国家心肺和血液研究所赞助的心血管研究网络（CVRN），这是一个多中心，基于健康计划的研究网络，为全美约1100万成员提供护理。通过四个参与CVRN中心的合作，我们建议组建一个大型，对诊断为心力衰竭并保留左心室收缩功能的当代不同成人队列进行研究，以检查以下三个特定目的：目的1。收集2000-2008年间患有心力衰竭并记录左心室收缩功能的成年人的大型、多样化的多中心队列，并描述最近可用心力衰竭治疗的实践模式。目标2。在整体和目标患者亚组中，确定心力衰竭和保留收缩功能的成人的死亡率、心力衰竭住院率和总资源利用率。目标3。鉴于该人群中有限的随机临床试验证据，对靶向治疗（即ACE抑制剂、β受体阻滞剂和醛固酮受体拮抗剂）的有效性和安全性进行初步评估，这些治疗已被证明对心力衰竭和收缩功能降低患者有益，并探索与慢性心力衰竭其他常用治疗（如利尿剂、地高辛、硝酸盐和他汀类药物）相关的结果。慢性心力衰竭的公共卫生负担是巨大的，影响着570万美国人，其中大多数人年龄在65岁或以上。超过一半的心力衰竭患者保留了左心室收缩功能，这种情况的预后仍然很差，我们很少有随机临床试验数据来指导治疗。拟议的研究将为当代不良事件发生率和不良结果预测因素提供关键和及时的见解，并为改善日益增长的心力衰竭和保留收缩功能患者的护理和结果提供潜在的方法。