BOSTON, March 7, 2024 /PRNewswire/ -- Sensible Medical, creator of the ReDS pulmonary congestion monitor, announces the publication of The ReDS-SAFE HF Trial; an international, multicenter, investigator initiated, randomized controlled trial, demonstrating a significant improvement in heart failure patients' clinical outcomes by utilizing Remote Dielectric Sensing (ReDS) for guiding heart failure management..

波士顿，2024年3月7日/PRNewswire/--红色肺充血监测仪的创始人Sensive Medical宣布发布红色安全HF试验；一项由研究者发起的国际多中心随机对照试验，通过利用远程介电传感（ReDS）指导心力衰竭管理，证明心力衰竭患者的临床结果显着改善。。

The trial, titled 'Remote Dielectric Sensing Before and After Discharge in Patients With ADHF: The ReDS-SAFE HF Trial,' has been published in the Journal of the American College of Cardiology: Heart Failure. The trial, conducted in US and Spain, was led by a team of esteemed researchers: Donna Mancini, Sean Pinney, Anuradha Lala, Jesus Alvarez-Garcia and Mercedes Rivas-Lasarte.

该试验题为“ADHF患者出院前后的远程介电传感：ReDS安全HF试验”，已发表在《美国心脏病学会杂志：心力衰竭》上。这项试验在美国和西班牙进行，由一组受人尊敬的研究人员领导：唐娜·曼奇尼、肖恩·平尼、阿努拉达·拉拉、耶稣·阿尔瓦雷斯·加西亚和梅赛德斯·里瓦斯·拉萨特。

A hundred ADHF patients were recruited and assessed daily with ReDS during hospitalization, and at the outpatient clinic post-discharge. The trial goal was to evaluate whether a heart failure management guided by ReDS in admitted patients is superior to the standard of care during a 1-month follow up.

招募了100名ADHF患者，并在住院期间和出院后的门诊每天使用ReDS进行评估。试验目标是评估在入院患者中由ReDS指导的心力衰竭管理是否优于1个月随访期间的护理标准。

The primary endpoint was a combination of death, HF readmission and worsening HF events..

主要终点是死亡，HF再入院和HF事件恶化的组合。。

The ReDS-SAFE HF trial results were presented at the THT conference in Boston by Dr. Alvarez-Garcia. A remarkable reduction in the primary composite endpoint of death, heart failure rehospitalization, or unplanned visits for heart failure at 1 month after discharge has been observed. The ReDS-guided strategy resulted in a hazard ratio of 0.094 (95% CI: 0.012-0.731; P = 0.005) which was mainly attributed to a reduction in HF rehospitalizations.

Alvarez Garcia博士在波士顿举行的THT会议上介绍了ReDS SAFE HF试验结果。观察到出院后1个月死亡，心力衰竭再住院或心力衰竭意外就诊的主要复合终点显着降低。ReDS指导的策略导致风险比为0.094（95%CI:0.012-0.731；P=0.005），这主要归因于HF再住院的减少。

Patients in the ReDS-guided arm also experienced a greater reduction, both absolute and relative, in ReDS values from admission to discharge compared to those in the routine care arm..

与常规护理组相比，ReDS引导组患者从入院到出院的ReDS值也经历了更大的绝对和相对降低。。

'The ReDS-SAFE HF trial demonstrates the importance of an adequate decongestion on patients status and outcome. Using ReDS system, we can monitor the decongestion process more objectively, from admission to discharge and at subsequent outpatient clinic follow-up. It enhances our HF management and reduces HF readmission rate' said Donne Mancini, MD, Trial PI from Mount Sinai Hospital, NY..

“ReDS SAFE HF试验证明了充分缓解患者状态和结局的重要性。使用ReDS系统，我们可以更客观地监测从入院到出院以及随后的门诊随访的解除充血过程。纽约西奈山医院试验PI医学博士多恩·曼奇尼（DonneMancini）说，它加强了我们的心衰管理，降低了心衰再入院率。。

Jesus Alvarez-Garcia, MD, PhD, head of advanced heart failure unit at Ramón y Cajal University Hospital commented: 'Our study represents a significant advancement in the management of acute heart failure. The implementation of the ReDS technology provides clinicians with a valuable tool to accurately assess lung fluid noninvasively, and ReDS guided strategy facilitates optimization of patient management by timely and precise interventions which lead to a better clinical outcome for the patients.'.

拉蒙·卡哈尔大学医院高级心力衰竭科主任、医学博士、博士耶稣·阿尔瓦雷斯·加西亚评论道：“我们的研究代表了急性心力衰竭管理的重大进步。ReDS技术的实施为临床医生提供了一个有价值的工具，可以无创地准确评估肺液，ReDS指导的策略通过及时准确的干预措施促进患者管理的优化，从而为患者带来更好的临床结果。”。

This trial emphasizes the potential of ReDS technology in revolutionizing the management of heart failure, paving the way for more personalized and effective patient care strategies.

这项试验强调了ReDS技术在彻底改变心力衰竭管理方面的潜力，为更个性化和有效的患者护理策略铺平了道路。

For more information on trial please visit ReDS-SAFE HF trial.

有关试用的更多信息，请访问Red SAFE HF试用版。

For more information on the ReDS technology please visit www.sensible-medical.com or contact info@sensible-medical.com

有关ReDS技术的更多信息，请访问www.sensible-medical.com或联系info@sensible-medical.com

SOURCE Sensible Medical

源敏感医疗