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Initiation of ReDS-SAFE HF II Trial for Advancing Heart Failure Management

by Amy

Boston, February 24, 2025 — At the THT conference, Dr. Jesus Alvarez-Garcia, head of the Advanced Heart Failure Unit at Ramón y Cajal Hospital in Madrid, announced the launch of the ReDS-SAFE HF II trial. This large-scale, multicenter study aims to validate the benefits of using ReDS (Remote Dielectric Sensing) to guide heart failure management.

Trial Details

The ReDS-SAFE HF II trial will enroll over 1,000 patients across 24 medical centers in Spain. It seeks to confirm whether ReDS-guided management improves patient outcomes within 30 days compared to standard care. Patients in the ReDS-guided group will undergo daily ReDS measurements during hospitalization and an additional assessment at a one-week follow-up visit. This approach aims to optimize pulmonary congestion management and reduce complications related to heart failure.

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Building on Previous Success

The trial builds on the success of the ReDS-SAFE HF study, which involved 100 patients with acute decompensated heart failure. That study showed that ReDS-guided management significantly reduced deaths, rehospitalizations, and unplanned visits within 30 days after discharge. The reduction was substantial, with a 90.6% decrease in these events.

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Goals and Support

The primary goal of the ReDS-SAFE HF II trial is to validate these findings and establish ReDS-guided management as a standard in heart failure treatment. The trial is supported by the Government of Spain, the Ministry of Science, Innovation and Universities, the Spanish Society of Cardiology, and Sensible Medical.

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Potential Impact

Dr. Alvarez-Garcia expressed excitement about the trial, stating, “By expanding the study to over 1,000 patients across multiple centers, we aim to further demonstrate the ability of ReDS-guided management to improve heart failure patient outcomes. This trial has the potential to transform how we manage heart failure during hospitalization and the vulnerable post-discharge period, offering a more personalized and effective strategy to reduce rehospitalizations and improve patient quality of life.”

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