The Atrial Fibrillation-Factor Identification to Risk Modification Study in CKD/ESRD

CKD/ESRD 风险调整研究的心房颤动因素识别

• 批准号: 10084289
• 负责人: WOLFGANG CHRISTOPH WINKELMAYER
• 金额: $ 68.85万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10084289
• 关键词: Adherence; American; Anticoagulants; Anticoagulation; Area; Arrhythmia; Atrial Fibrillation; Binding Proteins; Biometry; Blood; Blood Tests; Cardiovascular system; Cessation of life; Chronic Kidney Failure; Complex; Conflict (Psychology); Data; Databases; Diagnosis; Dialysis procedure; Disease; Dose; Effectiveness; Electrophysiology (science); Embolism; End stage renal failure; Enrollment; Epidemiology; Erythropoiesis; Evaluation; Event; Factor V; Female; Ferritin; Food; Foundations; Funding; Future; General Population; Germany; Hemoglobin; Hemorrhage; Heterogeneity; Hispanics; Industry; Intravenous; Investigation; Iron; Ischemic Stroke; Kidney Diseases; Kidney Failure; Kidney Transplantation; Medicare; Methods; Modification; Monitor; Myocardial Infarction; Nephrology; Newly Diagnosed; Observational Study; Oral; Outcome; Outcome Study; Patient-Focused Outcomes; Patients; Pattern; Persons; Pharmaceutical Preparations; Pharmacoepidemiology; Population; Prevention; Prevention strategy; Randomized; Randomized Controlled Trials; Renal dialysis; Research; Risk; Safety; Statistical Data Interpretation; Statistical Methods; Stroke; Stroke prevention; Testing; Therapeutic; Thrombin; Time; Transferrin; Transplantation; Use Effectiveness; Vitamin K; Warfarin; Work; adverse outcome; clinical practice; comparative effectiveness; comparative safety; design; effectiveness evaluation; experience; experimental study; gastrointestinal; heart rhythm; high risk; high risk population; improved; inhibitor/antagonist; interest; mortality; novel drug class; novel therapeutics; older patient; patient population; pill; placebo controlled trial; safety outcomes; thrombotic; treatment group; trend

Project Summary/Abstract More than 1.5 million Americans have advanced chronic kidney disease or irreversible kidney failure requiring dialysis or kidney transplantation. Atrial fibrillation is the most common heart rhythm disorder which is particularly common among patients with kidney disease: more than a quarter of patients with irreversible kidney failure have atrial fibrillation. Persons with atrial fibrillation are at increased risk of thromboembolic events, especially stroke, and death. Oral anticoagulation (blood dilution using pills) has been shown to reduce these risks in the general population free from advanced kidney disease. While warfarin, a vitamin K blocker, has been the mainstay treatment for this, it is marred by important shortfalls including numerous interactions with other drugs or foods and the need to frequently monitor treatment through regular blood tests and adjust the dose. However, since 2010 a new class of drugs has come to market and started to replace warfarin. These so called direct oral anticoagulants (DOACs) do not require blood monitoring, have fewer interactions, and can be taken at a fixed dose. However, the evidence is lacking on various strategies for the prevention of ischemic stroke and mortality in patients with advanced kidney disease who also have atrial fibrillation. The proposed project will focus on a comprehensive evaluation of the effectiveness and safety of these newer DOACs in patients with advanced chronic kidney disease and among those with irreversible kidney failure. We will examine all hypotheses in 2 populations: a) Aim 1: Medicare- insured persons with diagnosed chronic kidney disease stages 4 or 5 (not on dialysis); and b) Aim 2: persons with irreversible kidney failure undergoing dialysis. Patients will be required to also be diagnosed with atrial fibrillation. We will then compare the occurrence of important events between persons receiving warfarin to persons using one of the DOACs. Study outcomes of interest will include stroke, heart attacks, bleeding events, and deaths. In Aim 3, we will identify patients on dialysis with newly diagnosed with atrial fibrillation who had previously not taken any oral anticoagulation and compare the same outcomes between patients who initiated DOAC treatment to otherwise similar patients not initiating any oral anticoagulation. We will use sophisticated statistical methods and analyses to achieve fair comparisons between treatment groups, as much as is possible without conducting a randomized experiment. Our findings will fill an important evidence gap and have the potential to immediately influence clinical practice, thus improving patient outcomes.

项目摘要/摘要 超过150万美国人患有慢性肾脏病或不可逆的肾脏 需要透析或肾脏移植的失败。心房颤动是最常见的心脏 节奏障碍在肾脏疾病患者中尤其常见：不仅仅是 四分之一的不可逆肾衰竭患者患有房颤。心房的人 纤颤的风险增加了血栓栓塞事件，尤其是中风和死亡的风险。口服 抗凝作用（使用药丸稀释）已显示可降低这些风险 人群没有晚期肾脏疾病。维生素K阻滞剂华法林（Warfarin）一直是 对此的主要待遇，它因重要的不足而损害 与其他药物或食物的相互作用，需要经常通过 定期进行血液检查并调整剂量。但是，自2010年以来 市场并开始取代华法林。这些所谓的直接口服抗凝剂（DOAC）做 不需要血液监测，相互作用较少，可以以固定剂量服用。 但是，证据缺乏预防缺血性中风的各种策略和 晚期肾脏疾病患者的死亡率也患有房颤。 拟议的项目将着重于对有效性和安全性的全面评估 在患有晚期慢性肾脏疾病的患者中，这些较新的DOAC在患有 不可逆转的肾衰竭。我们将研究2个人群中的所有假设：a）目标1：Medicare- 有被诊断为慢性肾脏疾病的被诊断阶段的被保险人（不在透析上）；和b） 目标2：患有透析的不可逆转肾衰竭的人。将需要患者 也被诊断为房颤。然后，我们将比较重要的 使用其中一个DOAC接收华法林的人之间的事件。学习 感兴趣的结果将包括中风，心脏病发作，出血事件和死亡。在AIM 3中，我们 将识别出透析患者，新诊断为房颤的患者以前 没有接受任何口服抗凝治疗，并比较患者之间的相同结果 开始对类似患者的DOAC治疗，而不会引发任何口服抗凝治疗。我们 将使用复杂的统计方法和分析来实现公平的比较 治疗组，在不进行随机实验的情况下尽可能多。我们的 调查结果将填补重要的证据差距，并有可能立即影响 临床实践，从而改善患者的预后。