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: 9885396
• 负责人: WOLFGANG CHRISTOPH WINKELMAYER
• 金额: $ 64.87万
• 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/9885396
• 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; 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; 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.

项目总结/摘要 超过150万美国人患有晚期慢性肾脏疾病或不可逆的肾脏疾病。 需要透析或肾移植的衰竭。心房颤动是最常见的心脏 节律紊乱在肾病患者中特别常见： 四分之一的不可逆性肾衰竭患者患有房颤。心房肌萎缩症患者 纤维性颤动的患者发生血栓栓塞事件（尤其是中风）和死亡的风险增加。口服 抗凝（使用药丸进行血液稀释）已被证明可以降低这些风险， 无晚期肾病的人群。而华法林，一种维生素K阻滞剂， 作为治疗这一疾病的主要手段， 与其他药物或食物的相互作用，以及需要经常监测治疗， 定期验血并调整剂量。然而，自2010年以来，一种新的药物已经出现， 市场，并开始取代华法林。这些所谓的直接口服抗凝剂（DOAC） 不需要血液监测，相互作用较少，并且可以以固定剂量服用。 然而，缺乏关于预防缺血性卒中的各种策略的证据， 晚期肾病合并房颤患者的死亡率。 拟议的项目将侧重于对有效性和安全性进行全面评估 在晚期慢性肾脏疾病患者和 不可逆肾衰竭我们将在2个人群中检验所有假设：a）目标1：医疗保险- 被诊断患有慢性肾病4期或5期（未接受透析）的投保人;以及B） 目标2：接受透析的不可逆性肾衰竭患者。要求患者 心房颤动的症状有哪些？然后我们将比较重要的 接受华法林的人与使用其中一种DOAC的人之间的事件。研究 关注的结果将包括中风、心脏病发作、出血事件和死亡。在目标3中，我们 将识别新诊断为房颤的透析患者， 未服用任何口服抗凝剂，并比较 开始DOAC治疗，其他类似患者未开始任何口服抗凝治疗。我们 将使用复杂的统计方法和分析，以实现公平的比较， 治疗组，尽可能不进行随机实验。我们 这些发现将填补一个重要的证据空白，并有可能立即影响 临床实践，从而改善患者的治疗效果。