ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure: the ReDS-SAFE HF II Trial

This clinical trial aims to determine whether a ReDS-guided treatment strategy is superior to the current standard of care for adults hospitalized with heart failure. Additionally, the study will evaluate the safety and cost-effectiveness of this approach.

The study seeks to answer the following key questions:

1. Does the ReDS-guided strategy reduce the risk of cardiovascular events during the first month following hospital discharge?
2. What is the safety profile of this treatment strategy?

Researchers will compare the ReDS-based strategy against the current standard of care. All participants will:

• Undergo daily assessments using the ReDS device throughout their hospitalization.
• Attend two follow-up visits post-discharge, scheduled at 2 weeks and 30 days.

Inclusion Criteria:

1. Hospitalized due to heart failure as the main reason, including the presence of symptoms and signs of congestion, regardless of the left ventricular ejection fraction (LVEF).
2. NT-proBNP greater than 1000 pg/L or BNP greater than 300 pg/L upon admission.

Exclusion Criteria:

1. Height less than 150 cm or greater than 190 cm or body mass index (BMI) less than 22 or greater than 39, conditions where the use of ReDS is not approved.
2. Patients requiring inotropes (levosimendan is allowed) or vasopressors upon admission, with mechanical support, or heart transplant recipients.
3. Any malformation or variant affecting the right lung anatomy (e.g., a pacemaker).
4. Patients with any heart disease requiring a planned surgical intervention (CABG, valve disease, or other) or percutaneous (TAVR, STE-ACS, mitral or tricuspid valve repair, CRT) during the clinical trial.
5. Chronic kidney disease with a GFR <20 or on hemodialysis.
6. Life expectancy less than 12 months due to non-cardiological origin.
7. Participation in another clinical trial with intervention.