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ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Summary
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.
Official title: ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure: the ReDS-SAFE HF II Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1014
Start Date
2026-01-29
Completion Date
2027-08-31
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Remote Dielectric Sensing System
The ReDS system consists of 2 sensors that are placed (sitting or supine) on the front (infraclavicular) and back (below the scapula) of the patient's right hemithorax and in 45 seconds accurately quantifies the proportion of fluid in the lung. The sensors are connected via 1 cable to a touchscreen monitor that easily guides the measurement process and stores this information. The accuracy of this technology has been validated with high-resolution chest computed tomography and invasive hemodynamic measurements with a Swan-Ganz catheter. Normal ReDS values range between 20% and 35% (i.e., 20-35% of the lung would be fluid). Above 35% is considered congestive, whereas below 20% the lung would be "dry" or dehydrated.
Blinded ReDS data
The responsible physician will not have access to the ReDS values and will adjust the treatment according to their clinical judgment and local practices. Discharge can be given if the clinical stability criteria are met.
Locations (25)
Ramón y Cajal University Hospital
Madrid, Madrid, Spain
Arnau de Vilanova University Hospital
Barcelona, Spain
Bellvitge University Hospital
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Vall d'Hebrón University Hospital
Barcelona, Spain
Reina Sofía University Hospital
Córdoba, Spain
Dr Josep Trueta University Hospital
Girona, Spain
12 de Octubre University Hospital
Madrid, Spain
Clínico San Carlos University Hospital
Madrid, Spain
Fundación Jiménez Díaz University Hospital
Madrid, Spain
Gregorio Marañón University Hospital
Madrid, Spain
La Paz University Hospital
Madrid, Spain
La Princesa University Hospital
Madrid, Spain
Puerta de Hierro Majadahonda University Hospital
Madrid, Spain
Virgen de la Victoria University Hospital
Málaga, Spain
Virgen de la Arrixaca
Murcia, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, Spain
San Juan Despí Moisès Broggi Hospital
Sant Joan Despí, Spain
Marqués de Valdecilla University Hospital
Santander, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Virgen de la Macarena University Hospital
Seville, Spain
Sant Joan XXIII University Hospital
Tarragona, Spain
Hospital General Universitario de Toledo
Toledo, Spain
Clínico University Hospital
Valencia, Spain