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

BOSTON, Feb. 24, 2025 /PRNewswire/ -- At the THT conference, Dr. Jesus Alvarez-Garcia, MD, PhD, head of Advanced Heart Failure Unit at Ramón y Cajal Hospital in Madrid, announced the launch of ReDS-SAFE HF II, a large-scale investigator-initiated trial designed to validate the benefits of ReDS guided heart failure management.

The multicenter trial will enroll over 1,000 patients across 24 medical centers in Spain to confirm whether ReDS-guided heart failure (HF) management improves 30-day patient outcomes compared to standard of care. Patients in the ReDS-guided arm will undergo daily ReDS measurements during hospitalization, along with an additional ReDS assessment at the one-week follow-up clinic visit to optimize pulmonary congestion management and reduce 30-day HF-related complications. 

The trial builds upon the success of the ReDS-SAFE HF study, also presented by Dr. Alvarez-Garcia at the conference. This multinational study, which enrolled 100 ADHF patients, demonstrated that ReDS-guided management significantly reduced death, HF rehospitalization, and unplanned HF visits at 30 days post-discharge (90.6% reduction, HR = 0.094, 95% CI: 0.012-0.731; P = 0.005). The ReDS approach was significantly effective in reducing HF rehospitalizations and showed a greater decline in ReDS values from admission to discharge compared to standard care.

The goal of ReDS-SAFE HF II trial is to validate these findings and establish ReDS-guided management as a standard of care 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.

"We are excited to initiate the ReDS-SAFE HF II trial, building on the promising results of the original study. 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 the way we manage heart failure during hospitalization and the at the vulnerable post-discharge period, offering a more personalized and effective strategy to reduce rehospitalizations and improve patient quality of life" said Dr. Alveraz-Garcia.

About the ReDS™ Pro System

The ReDS™ Pro System is an accurate non-invasive device for assessing pulmonary congestion. Assessment with the aid of the point-of-care ReDS™ Pro System has helped physicians and nurses at facilities across the world to better manage their patients' heart failure, with the goal of avoiding readmissions.

About Sensible Medical Innovations

Sensible Medical Innovations sets out to develop a new standard of care in lung fluid management and strives to deliver cutting-edge solutions that positively impact heart failure patients' lives. Sensible developed the ReDS™ medical radar technology that stems from defense "see through wall" applications and holds FDA 510(k) clearance and CE mark as well as many other regulatory approvals for the technology. The company is dedicated to innovation, quality, customer satisfaction and adherence to stringent regulatory standards and is committed to becoming a trusted partner in improving health and well-being.

For additional information about ReDS™ or Sensible Medical Innovations, visit www.sensible-medical.com or contact [email protected]

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SOURCE Sensible Medical