Imamura Teruhiko, Akazawa Yasuhiro, Saito Shunsuke, Sakata Yasushi, Miyagawa Shigeru, Yamada Tomomi, Asanoi Hidetsugu, Kinugawa Koichiro
Second Department of Internal Medicine, University of Toyama, Toyama 930-0194, Japan.
Department of Cardiovascular Medicine, Graduate School of Medicine, Osaka University, Suita 565-0871, Japan.
J Clin Med. 2025 Jul 1;14(13):4653. doi: 10.3390/jcm14134653.
: Telemonitoring aimed at detecting subclinical heart failure and facilitating medication up-titration offers a promising approach to reducing heart failure hospitalizations. Our team has recently developed a non-invasive metric called "respiratory stability time (RST)", which quantifies respiratory instability, a surrogate marker of subclinical worsening heart failure. A decrease in RST below 20 s predicts the onset of worsening heart failure within 28 days. However, the clinical utility of RST-guided management in reducing mortality and heart failure hospitalizations remains uncertain. : The Innovative Tele-Monitoring Environment To Halt Ongoing Deterioration of Heart Failure-III (ITMETHOD-HF-III) is a non-blinded, interventional, multicenter, single-arm study. Eighty heart failure patients with a history of at least two prior hospitalizations for heart failure will be enrolled. After validating the robustness of RST measurements, participants will be monitored for 1.5 years through daily RST measurements. Mandatory up-titration of heart failure medications will be started if RST values decrease below 20 s for two consecutive days or decrease progressively below 30 s over 10-90 days from RST values above 45 s maintained for over 1 month, irrespective of the presence of heart failure signs/symptoms. Medication adjustment will continue until RST exceeds 30 s. The study will compare a composite endpoint of heart failure hospitalization and cardiac death between the present RST-guided group and a historical control group from the ITMETHOD-HF-II trial, in which management was based on patients' symptoms. We anticipate that the precent ITMETHOD-HF-III study will demonstrate that mandatory, RST-guided heart failure management significantly reduces the incidence of the primary composite endpoint-heart failure hospitalization and cardiac death-compared with symptom-guided standard care in the historical control group (ITMETHOD-HF-II). : The ITMETHOD-HF-III study aims to demonstrate the clinical efficacy of RST-guided management in reducing heart failure hospitalization rates and cardiac mortality by enabling early detection of subclinical heart failure and facilitating timely medication adjustments, irrespective of heart failure signs/symptoms. If successful, RST-guided management could establish a new standard for telemonitoring heart failure patients in outpatient settings.
旨在检测亚临床心力衰竭并促进药物滴定的远程监测为减少心力衰竭住院提供了一种很有前景的方法。我们的团队最近开发了一种名为“呼吸稳定时间（RST）”的非侵入性指标，它可以量化呼吸不稳定，这是亚临床心力衰竭恶化的替代指标。RST降至20秒以下预示着28天内心力衰竭恶化的发生。然而，RST指导管理在降低死亡率和心力衰竭住院率方面的临床效用仍不确定。
心力衰竭创新远程监测环境以阻止持续恶化-III（ITMETHOD-HF-III）是一项非盲法、干预性、多中心、单臂研究。将招募80名有至少两次心力衰竭住院史的心力衰竭患者。在验证RST测量的稳健性后，将通过每日测量RST对参与者进行1.5年的监测。如果RST值连续两天降至20秒以下，或从持续超过1个月的45秒以上的RST值在10 - 90天内逐渐降至30秒以下，无论是否存在心力衰竭体征/症状，都将开始强制性增加心力衰竭药物剂量。药物调整将持续到RST超过30秒。该研究将比较当前RST指导组与ITMETHOD-HF-II试验的历史对照组之间心力衰竭住院和心源性死亡的复合终点，ITMETHOD-HF-II试验的管理是基于患者症状。我们预计，ITMETHOD-HF-III研究将表明，与历史对照组（ITMETHOD-HF-II）中基于症状的标准护理相比，强制性的、RST指导的心力衰竭管理显著降低了主要复合终点——心力衰竭住院和心源性死亡的发生率。
ITMETHOD-HF-III研究旨在证明RST指导管理在降低心力衰竭住院率和心脏死亡率方面的临床疗效，通过能够早期检测亚临床心力衰竭并促进及时的药物调整，而不考虑心力衰竭体征/症状。如果成功，RST指导管理可以为门诊环境中远程监测心力衰竭患者建立一个新标准。
