The ReDS-SAFE HF II Trial, a large multicenter, investigator-initiated randomized controlled study, has officially begun in Spain.
Funded by the Instituto de Salud Carlos III and the Spanish Society of Cardiology, the trial will further evaluate whether ReDS-guided congestion management can improve outcomes in patients hospitalized with heart failure and during early post-discharge follow-up.
ReDS-SAFE HF II plans to enroll more than 1,000 patients across 25 clinical sites in Spain.
Enrollment has started at leading hospitals in:
The study is led by Dr. Jesús Álvarez-García, Head of the Advanced Heart Failure Unit at Ramón y Cajal University Hospital.
The trial will assess whether ReDS-guided management during hospitalization and early outpatient follow-up can:
These outcomes will be compared with standard of care.
Patients in the ReDS-guided arm will receive:
This approach provides objective, quantitative pulmonary congestion data, helping clinicians fine-tune therapy during a high-risk transition period.
Residual pulmonary congestion is often missed using standard clinical assessment alone. Dr. Álvarez-García noted that daily objective pulmonary data may help ensure patients are truly optimized before discharge, with the aim of breaking the cycle of early readmissions.
ReDS-SAFE HF II builds on results from the original ReDS-SAFE HF study, published in JACC: Heart Failure.
That study reported:
The findings supported the clinical value of non-invasive, quantitative lung fluid assessment in hospitalized heart failure patients.
ReDS™ Pro is a non-invasive point-of-care device designed to assess pulmonary congestion.
The system has:
It is used by physicians and nurses worldwide to support better heart failure management and reduce readmissions.
Sensible Medical Innovations develops technologies aimed at establishing a new standard of care in lung fluid management.
The company focuses on delivering clinically validated, regulatory-compliant solutions that improve outcomes for patients with heart failure.