Using a lung fluid sensor to guide treatment in heart failure hospital stays
Tests a fluid-measuring device to guide care in adults hospitalized with heart failure.
Plain-language title generated from the registry record
Registry title: ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure
Key facts
- Where
- Barcelona, Córdoba, Girona, Madrid, Málaga, Murcia, Salamanca, Sant Joan Despí, Santander, Santiago de Compostela, Seville, Tarragona, Toledo, and Valencia, SpainSee the 25 sites
Where in Spain
- Arnau de Vilanova University HospitalBarcelona, SpainNot yet recruiting
- Bellvitge University HospitalBarcelona, SpainTaking people
- Hospital ClinicBarcelona, SpainNot yet recruiting
- Hospital del MarBarcelona, SpainTaking people
- Vall d'Hebron University HospitalBarcelona, SpainNot yet recruiting
- Reina Sofia University HospitalCórdoba, SpainTaking people
- Dr Josep Trueta University HospitalGirona, SpainTaking people
- 12 de Octubre University HospitalMadrid, SpainTaking people
- Clínico San Carlos University HospitalMadrid, SpainNot yet recruiting
- Fundación Jiménez Díaz University HospitalMadrid, SpainNot yet recruiting
- Gregorio Marañón University HospitalMadrid, SpainNot yet recruiting
- La Paz University HospitalMadrid, SpainTaking people
- La Princesa University HospitalMadrid, SpainNot yet recruiting
- Puerta de Hierro Majadahonda University HospitalMadrid, SpainTaking people
- Ramón y Cajal University HospitalMadrid, SpainTaking people
- Virgen de la Victoria University HospitalMálaga, SpainTaking people
- Virgen de la ArrixacaMurcia, SpainNot yet recruiting
- Complejo Asistencial Universitario de SalamancaSalamanca, SpainNot yet recruiting
- San Juan Despí Moisès Broggi HospitalSant Joan Despí, SpainTaking people
- Marqués de Valdecilla University HospitalSantander, SpainNot yet recruiting
- Complejo Hospitalario Universitario de SantiagoSantiago de Compostela, SpainTaking people
- Virgen de la Macarena University HospitalSeville, SpainNot yet recruiting
- Sant Joan XXIII University HospitalTarragona, SpainNot yet recruiting
- Hospital General Universitario de ToledoToledo, SpainNot yet recruiting
- Clínico University HospitalValencia, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Trial code
- NCT07484009
- Record updated
- 19 March 2026
- Original description
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.Read full original descriptionShow less
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: 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); NT-proBNP greater than 1000 pg/L or BNP greater than 300 pg/L upon admission.
Exclusion: 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; Patients requiring inotropes (levosimendan is allowed) or vasopressors upon admission, with mechanical support, or heart transplant recipients; 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; Chronic kidney disease with a GFR <20 or on hemodialysis; Any malformation or variant affecting the right lung anatomy (e.g., a pacemaker); Life expectancy less than 12 months due to non-cardiological origin; Participation in another clinical trial with intervention.