CAMARO-ESRD: Cardiac Arrhythmia Monitoring and Related Outcomes in End Stage Renal Disease Patients

CAMARO-ESRD：终末期肾病患者的心律失常监测和相关结果

• 批准号: 9238909
• 负责人: Tariq Shafi
• 金额: $ 81.7万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-12-15 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9238909
• 关键词: Affect; Area; Arrhythmia; Atrial Fibrillation; Bicarbonates; Bradyarrhythmias; Bradycardia; Calcium; Cardiac; Cardiovascular Diseases; Cessation of life; Characteristics; Clinical; Cohort Studies; Comorbidity; Data; Death Rate; Development; Devices; Electrolytes; End stage renal failure; Event; Fluid Shifts; General Population; Health Policy; Heart; Heart Arrest; Heart Atrium; Heart failure; Hemodialysis; Hospitalization; Hypotension; Implant; Injury; Lead; Maryland; Mediating; Monitor; Morbidity - disease rate; Myocardial Stunning; Outcome; Outcome Study; Patient Recruitments; Patients; Pharmaceutical Preparations; Potassium; Prevalence; Preventive; Prospective cohort study; Public Health; Race; Risk; Risk Assessment; Risk Estimate; Sample Size; Testing; Time; Ultrafiltration; Uremia; Ventricular; Ventricular Arrhythmia; Ventricular Fibrillation; Ventricular Tachycardia; Virginia; Weight Gain; Wireless Technology; clinical practice; cohort; cost; design; follow-up; heart rhythm; high risk; mortality; prevent; racial difference; subcutaneous; sudden cardiac death

ABSTRACT End stage renal disease (ESRD) requiring hemodialysis (HD) affects >400,000 patients in the US and is associated with high morbidity, mortality, and costs. While HD can prevent immediate death due to uremia, the long-term survival of patients on HD remains poor. Median survival from the time of initiating HD is 3 years and 5-year survival is <35%. Over 50% of all deaths in HD patients are due to cardiovascular disease (CVD) and 50% of these (25% of all deaths) are sudden cardiac deaths (SCD). The high rates of SCD in HD patients have not changed in recent decades. The key barrier to progress in reducing SCD rates in HD patients is our limited understanding of the mechanisms underlying SCD. It has been assumed that the arrhythmic mechanisms for SCD in HD were the same as in the general population and that the majority of cases were due to ventricular tachycardia / ventricular fibrillation (VT/VF), but other mechanisms have also been described in HD including bradyarrhythmias, asystole and non-arrhythmic events. Little is known regarding the prevalence of these mechanisms in HD and this is widely recognized as a major clinical challenge. In addition, several characteristics of the HD session may contribute to arrhythmic risk. The typical dialysate prescription, low in potassium and calcium and high in bicarbonate concentrations, and rapid fluid shifts and hypotension during HD may further increase the risk of arrhythmias. Previous studies of arrhythmic risk in HD patients have been limited by the lack of continuous cardiac monitoring or by small sample sizes. We propose to conduct the Cardiac Arrhythmia Monitoring and Related Outcomes in HD (CAMARO- HD) Study, a cohort study of the risk of developing cardiac arrhythmias and their associated outcomes among 1,000 patients recruited within the first 6 months of initiating HD. We will implant a subcutaneous cardiac monitor (Reveal LINQ) in each patient to continuously record the cardiac rhythm and identify all episodes of VT/VF, bradycardia, asystole, and atrial fibrillation during 3 years of follow-up. We will then evaluate the association of arrhythmic events and arrhythmic burden with study outcomes (all-cause mortality and heart failure hospitalization). CAMARO-HD will also test the hypothesis that specific characteristics of the HD session contribute to arrhythmic risk and will assess if differences in arrhythmic burden between Black and White patients mediate the well-known race-survival paradox in HD. CAMARO-HD will be the largest cohort of HD patients with long-term continuous cardiac monitoring and precise information on ventricular and atrial arrhythmic episodes with a sample size large enough to quantify their clinical consequences in terms of mortality and heart failure hospitalization. CAMARO-HD will also provide actionable information related to the arrhythmic mechanisms responsible for deaths or heart failure hospitalizations and to the association of specific characteristics of the HD session with arrhythmic events. This information will directly modify clinical practice and will inform the design of preventive trials.

摘要 终末期肾病(ESRD)需要血液透析(HD)影响美国和美国的40万患者 与高发病率、死亡率和成本有关。虽然HD可以防止尿毒症导致的直接死亡， HD患者的长期存活率仍然很低。开始HD后的中位生存期为3年 5年存活率为35%。在HD患者中，超过50%的死亡是由于心血管疾病(CVD) 其中50%(占所有死亡人数的25%)是心脏性猝死(SCD)。血液透析患者SCD的高发生率 近几十年来都没有改变。在降低HD患者SCD发病率方面取得进展的关键障碍是我们的 对SCD潜在机制的了解有限。人们一直认为，心律失常 HD患者的SCD机制与普通人群相同，大多数病例是 由于室性心动过速/室颤(VT/VF)，但也描述了其他机制 HD包括缓慢性心律失常、停搏和非心律失常事件。人们对此知之甚少 这些机制在HD中的流行，这被广泛认为是一个重大的临床挑战。此外, HD课程的几个特点可能导致心律失常的风险。典型的透析液配方， 钾和钙含量低，碳酸氢盐浓度高，体液变化快，血压低 HD期间可能会进一步增加心律失常的风险。先前关于HD患者心律失常风险的研究已经 由于缺乏持续的心脏监测或样本量较小，这两种方法都受到限制。 我们建议对HD患者进行心律失常监测及相关结局(Camaro- HD)研究，一项关于以下人群发生心律失常风险及其相关结局的队列研究 在开始透析的前6个月内招募了1,000名患者。我们将植入一个皮下心脏 对每个患者进行监测(显示LINQ)，以持续记录心率并识别所有发作 随访3年，VT/VF、心动过缓、停搏、心房颤动。然后我们将评估 心律失常事件和心律失常负担与研究结果(全因死亡率和心脏)的关系 失败住院)。Camaro-HD还将测试假设，HD的特定特征 会议会增加心律失常的风险，并将评估黑人和黑人在心律失常负担方面的差异 白人患者在HD中调解了众所周知的种族生存悖论。 Camaro-HD将成为接受长期持续心脏监测的最大HD患者队列 以及关于室性和房性心律失常发作的准确信息，样本量足够大， 根据死亡率和心力衰竭住院时间量化它们的临床后果。Camaro-HD将 还提供与导致死亡或心脏的心律失常机制有关的可操作信息 失败的住院以及HD会议的特殊特征与心律失常的关联 事件。这些信息将直接修改临床实践，并将为预防性试验的设计提供信息。