Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial
Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial
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DOI：
10.1016/s0140-6736(14)61176-4
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发表时间：
2014-08-16
期刊：
影响因子：
168.9
通讯作者：
Sogaard, Peter
中科院分区：
文献类型：
--
作者：
Hindricks, Gerhard;Taborsky, Milos;Sogaard, Peter
越来越多的心力衰竭患者接受具有远程监测功能的植入式心律转复除颤器（ICDs）或心脏再同步除颤器（CRT-Ds）。通过基于植入物的远程监测，早期发现恶化的心力衰竭，或诱发心力衰竭恶化的上游因素，可能使先发制人的干预和改善结果成为可能，但证据不足。我们在一项名为in - time的临床试验中调查了这种可能性。方法：我们在澳大利亚、欧洲和以色列的36个三级临床中心和医院进行了这项随机对照试验。我们招募了慢性心力衰竭，NYHA II-III级症状，射血分数不超过35%，最佳药物治疗，无永久性房颤，近期双室ICD或CRT-D植入的患者。在1个月的磨合期后，患者被随机（1:1）分配到除标准护理外的自动、日常、基于植入物的多参数远程监测组或不进行远程监测的标准护理组。调查人员没有被隐瞒治疗分配。除非由于远程监测结果而与患者联系，否则患者不被分配。随访1年。主要结局指标是综合临床评分，包括全因死亡、因心力衰竭住院过夜、NYHA分级变化和患者总体自我评估变化，针对意向治疗人群。该试验已在ClinicalTrials.gov注册，注册号为NCT00538356。我们招募了716例患者，其中664例随机分配（333例远程监测组，331例对照组）。平均年龄65.5岁，平均射血分数26%。285例（43%）患者为NYHA功能II级，378例（57%）患者为NYHA功能III级。大多数患者接受了crt - d治疗（390例，58.7%）。1年后，远程监护组333例患者中63例（18.9%）与对照组331例患者中90例（27.2%）（p=0.013）的综合评分恶化（优势比0.63,95% CI 0.43-0.90）。10对27例患者在随访期间死亡。自动的、日常的、基于植入物的、多参数的远程监护可以显著改善心衰患者的临床结果。这种远程监护是可行的，应该在临床实践中应用。
Background An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial.Methods We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II-III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1: 1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT00538356.Findings We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65.5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58.7%). At 1 year, 63 (18.9%) of 333 patients in the telemonitoring group versus 90 (27.2%) of 331 in the control group (p=0.013) had worsened composite score (odds ratio 0.63, 95% CI 0.43-0.90). Ten versus 27 patients died during follow-up.Interpretation Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure. Such telemonitoring is feasible and should be used in clinical practice.