ReDS-SAFE HF II Trial Initiated - Large Randomized Controlled Study to Expand Evidence for ReDS-Guided Heart Failure Management

MADRID, Jan. 28, 2026 /PRNewswire/ -- The ReDS-SAFE HF II Trial, a large multicenter investigator-initiated randomized controlled study, funded by both the Instituto de Salud Carlos III and the Spanish Society of Cardiology, has officially commenced. The trial is designed to further evaluate the clinical impact of ReDS-guided management on outcomes in patients hospitalized with heart failure and during the early post-discharge period.

ReDS-SAFE HF II plans to enroll more than 1,000 patients across 25 sites in Spain. Enrollment has begun this week in Madrid and Barcelona at Hospital Universitario Ramón y Cajal and Hospital Universitario Puerta de Hierro (Madrid), and Hospital del Mar and Hospital Moisès Broggi (Barcelona).

The trial is led by Dr. Jesús Álvarez-García, Head of the Advanced Heart Failure Unit at Ramón y Cajal University Hospital. ReDS-SAFE HF II will assess whether ReDS-guided congestion management during hospitalization and early post-discharge follow-up can reduce 30-day mortality, heart-failure rehospitalizations, and unplanned heart-failure-related visits compared with standard of care.

Patients randomized to the ReDS-guided arm will undergo daily ReDS measurements during hospitalization, along with an additional assessment at the early outpatient follow-up visit. This approach is intended to provide objective pulmonary congestion assessment and support more informed clinical management decisions during the vulnerable transition-of-care period.

"Standard clinical assessment often misses residual congestion before discharge. The ReDS-SAFE HF II trial allows us to utilize objective pulmonary data to fine-tune our management strategies daily. Our goal is to ensure patients are truly optimized before they leave the hospital, breaking the cycle of readmissions." said Dr. Alveraz-Garcia.

The ReDS-SAFE HF II trial builds on the results of the original ReDS-SAFE HF study, which demonstrated a 90.6% reduction in the composite endpoint of 30-day mortality, heart-failure rehospitalization, and unplanned visits (HR 0.094; p = 0.003) in the study population and published in JACC: Heart Failure. These findings highlighted the clinical value of non-invasive, quantitative lung fluid assessment to support better decision-making in hospitalized heart-failure patients.

About the ReDS™ Pro System

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

About Sensible Medical

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. The ReDS™ Pro system is a non-invasive medical radar device with FDA 510(k) clearance, CE mark, and additional global regulatory approvals.

Sensible Medical is committed to quality, clinical rigor, and adherence to stringent regulatory standards.

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

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SOURCE Sensible Medical