#Spain #Madrid #Heart Failure #Sensible Medical #ReDS-SAFE

ReDS-SAFE HF II Trial: A Revolutionary Approach to Heart Failure Management

The ReDS-SAFE HF II Trial is a significant initiative that aims to enhance heart failure management through advanced monitoring techniques. Officially launched in January 2026, this extensive multicenter, investigator-initiated randomized controlled study is funded by both Instituto de Salud Carlos III and the Spanish Society of Cardiology. Led by Dr. Jesús Álvarez-García from the Ramón y Cajal University Hospital, the trial aims to enroll over 1,000 patients across 25 medical centers in Spain, including major hospitals in Madrid and Barcelona.

The trial focuses on the ReDS™ Pro System, a non-invasive device that assesses pulmonary congestion, providing healthcare professionals with vital data to manage heart failure more effectively. Early elements of the trial indicate the system's potential to significantly improve patient outcomes post-discharge.

Objectives of the Trial

The primary goal of the ReDS-SAFE HF II Trial is to evaluate whether patients receiving ReDS-guided congestion management during hospitalization and early follow-up can experience reduced risk concerning:

• - 30-day mortality rates
• - Unplanned heart failure rehospitalizations
• - Heart failure-related visits

Randomized patients will receive daily assessments with the ReDS System during their hospital stay, with another evaluation scheduled for their initial outpatient follow-up. This routine aims to ensure that any residual pulmonary congestion is detected and managed appropriately, optimizing patient outcomes during a critical transition phase of their care.

Importance of the Study

Heart failure often exacerbates health risks leading to frequent readmissions, usually arising from unnoticed congestion symptoms prior to discharge. The ReDS-SAFE HF II Trial's innovative approach seeks to bridge this gap in standard clinical practices by integrating real-time data into patient management. As Dr. Álvarez-García aptly puts it, "Utilizing objective pulmonary data could enable us to fine-tune management strategies daily, reducing the cycle of readmissions and improving patient care."

Previous Study Insights

This current trial builds on the foundations laid by the earlier ReDS-SAFE HF study. The previous research demonstrated remarkable results, showing a 90.6% reduction in a composite endpoint measuring mortality, rehospitalizations, and unplanned visits among participants. Published in the JACC Heart Failure journal, the study underscored the effectiveness of using non-invasive, quantitative assessments of lung fluid to inform better decision-making in hospital settings.

About the ReDS™ Pro System

The ReDS™ Pro System represents a significant advancement in heart failure management. This point-of-care device has earned various regulatory approvals, including FDA 510(k) clearance and CE marking, demonstrating its reliability and effectiveness in clinical settings worldwide. The goal of the system is to provide healthcare teams with accurate tools to manage patient care, ultimately aiming to minimize the risk of readmissions.

Sensible Medical Innovations

Sensible Medical Innovations is at the forefront of cardiology treatments, focusing on setting new standards in lung fluid management. Committed to clinical excellence, the company strives to integrate cutting-edge solutions in heart failure management while adhering to rigorous quality and regulatory standards.

For more details regarding Sensible Medical and the ReDS™ Pro System, interested parties can visit www.sensible-medical.com or contact [email protected].

The initiation of the ReDS-SAFE HF II trial marks a pivotal step in improving the care strategies for patients suffering from heart failure, showing promise to change the landscape of heart failure management efficiently and effectively.