RecruitingNot ApplicableNCT07484009

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


Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Enrollment

1,014 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device-guided approach to treating fluid buildup (congestion) in patients hospitalized for heart failure. The device, called ReDS (Remote Dielectric Sensing), measures the amount of fluid in the lungs non-invasively. Researchers want to see if using this device to guide diuretic (water pill) treatment leads to better outcomes than standard care. **You may be eligible if...** - You are hospitalized primarily because of heart failure with signs of fluid buildup (shortness of breath, leg swelling, etc.) - Your blood levels of a heart stress marker (NT-proBNP or BNP) are elevated on admission **You may NOT be eligible if...** - You are shorter than 150 cm or taller than 190 cm, or your BMI is under 22 or over 39 (as the ReDS device is not validated in these ranges) - You need intravenous medications to support your heart (inotropes, vasopressors) or mechanical heart support - You have an abnormality affecting your right lung (including a pacemaker on that side) - You are scheduled for heart surgery or a procedure (bypass surgery, valve repair, TAVR, etc.) during the trial - You have severe kidney disease (GFR under 20) or are on dialysis - Your life expectancy is less than 12 months due to a non-heart condition - You are already enrolled in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERemote 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.

DEVICEBlinded 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

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