Sensible Medical announces Successful IIS RCT Publication - The ReDS-SAFE HF Trial

2024-03-07

临床研究临床结果

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.

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

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. 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.

"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.

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."

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.

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

For more information on the ReDS technology please visit www.sensible-medical.com or contact [email protected]

SOURCE Sensible Medical

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