ReDS-guided decongestion for people hospitalized with heart failure

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

This test will see if using a ReDS chest sensor to guide fluid removal helps adults hospitalized for heart failure have fewer heart-related problems in the month after discharge.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1014 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (other)
• Locations: 25 sites (Madrid, Madrid and 24 other locations)
• Trial ID: NCT07484009 on ClinicalTrials.gov

What this trial studies

This randomized interventional study compares a ReDS-guided decongestion strategy to usual care in adults admitted for acute heart failure with signs of congestion and elevated natriuretic peptides. Participants will have daily ReDS measurements during hospitalization and will be randomized to treatment guided by those measurements or to standard care with ReDS data blinded. Investigators will track cardiovascular events in the first 30 days after discharge, and will monitor safety and costs of the approach. Two follow-up visits are scheduled at about 2 weeks and 30 days after discharge to capture outcomes and adverse events.

Who should consider this trial

Good fit: Adults hospitalized primarily for heart failure with clinical signs of congestion and admission NT-proBNP >1000 pg/L or BNP >300 pg/L, and with height and BMI within the ReDS-approved ranges, are ideal candidates.

Not a fit: Patients who need inotropes or vasopressors, have mechanical circulatory support or planned cardiac surgery/intervention, have incompatible lung anatomy or height/BMI, severe kidney failure on dialysis, or life expectancy under 12 months are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the ReDS-guided approach could reduce early post-discharge heart-related events and help tailor diuretic therapy to decrease rehospitalizations and costs.

How similar studies have performed: Some prior studies have shown ReDS can detect lung fluid and guide outpatient management, but using ReDS-guided decongestion in hospitalized patients to reduce early post-discharge events is relatively novel.

Eligibility criteria

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.

Where this trial is running

Madrid, Madrid and 24 other locations

• Ramón y Cajal University Hospital — Madrid, Madrid, Spain (RECRUITING)
• Arnau de Vilanova University Hospital — Barcelona, Spain (NOT_YET_RECRUITING)
• Bellvitge University Hospital — Barcelona, Spain (RECRUITING)
• Hospital Clinic — Barcelona, Spain (NOT_YET_RECRUITING)
• Hospital del Mar — Barcelona, Spain (RECRUITING)
• Vall d'Hebrón University Hospital — Barcelona, Spain (NOT_YET_RECRUITING)
• Reina Sofía University Hospital — Córdoba, Spain (RECRUITING)
• Dr Josep Trueta University Hospital — Girona, Spain (RECRUITING)
• 12 de Octubre University Hospital — Madrid, Spain (RECRUITING)
• Clínico San Carlos University Hospital — Madrid, Spain (NOT_YET_RECRUITING)
• Fundación Jiménez Díaz University Hospital — Madrid, Spain (NOT_YET_RECRUITING)
• Gregorio Marañón University Hospital — Madrid, Spain (NOT_YET_RECRUITING)
• La Paz University Hospital — Madrid, Spain (RECRUITING)
• La Princesa University Hospital — Madrid, Spain (NOT_YET_RECRUITING)
• Puerta de Hierro Majadahonda University Hospital — Madrid, Spain (RECRUITING)
• Virgen de la Victoria University Hospital — Málaga, Spain (RECRUITING)
• Virgen de la Arrixaca — Murcia, Spain (NOT_YET_RECRUITING)
• Complejo Asistencial Universitario de Salamanca — Salamanca, Spain (NOT_YET_RECRUITING)
• San Juan Despí Moisès Broggi Hospital — Sant Joan Despí, Spain (RECRUITING)
• Marqués de Valdecilla University Hospital — Santander, Spain (NOT_YET_RECRUITING)
• Complejo Hospitalario Universitario de Santiago — Santiago de Compostela, Spain (RECRUITING)
• Virgen de la Macarena University Hospital — Seville, Spain (NOT_YET_RECRUITING)
• Sant Joan XXIII University Hospital — Tarragona, Spain (NOT_YET_RECRUITING)
• Hospital General Universitario de Toledo — Toledo, Spain (NOT_YET_RECRUITING)
• Clínico University Hospital — Valencia, Spain (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Jesús Álvarez-García, MD, PhD — Ramón y Cajal University Hospital, Madrid, Spain
• Study coordinator: Jesús Álvarez-García, MD, PhD

Conditions: Acute Heart Failure, Heart Failure, Heart Failure Hospitalization, Heart failure, Congestion, ReDS, Fluid Overload, Randomized Clinical Trial