ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

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.

Conditions

• Acute Heart Failure (AHF)
• Heart Failure (for Example, Fluid Overload)
• Heart Failure Hospitalization

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital San Carlos, Madrid

  collaborator OTHER

• Hospital Universitario Fundación Jiménez Díaz

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• Hospital Universitari de Bellvitge

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• Hospital Sant Joan Despí Moisès Broggi

  collaborator UNKNOWN

• Hospital Arnau de Vilanova

  collaborator OTHER

• Hospital Universitario Virgen de la Arrixaca

  collaborator OTHER

• Complejo Hospitalario Universitario de Santiago

  collaborator OTHER

• Salamanca University Hospital

  collaborator OTHER

• Complejo Hospitalario Toledo

  collaborator OTHER

• Hospital Universitario Virgen Macarena

  collaborator OTHER

• Hospital Universitario Reina Sofia de Cordoba

  collaborator OTHER_GOV

• Hospital Universitario Virgen de la Victoria

  collaborator OTHER

• Hospital Universitario Marqués de Valdecilla

  collaborator OTHER

• Hospital Clínico Universitario de Valencia

  collaborator OTHER

• Centro Nacional de Investigaciones Cardiovasculares Carlos III

  collaborator UNKNOWN

• Puerta de Hierro University Hospital

  collaborator OTHER

• La Princesa University Hospital Madrid

  collaborator UNKNOWN

• University Hospital of Girona Dr. Josep Trueta

  collaborator NETWORK

• Joan XXIII University Hospital

  collaborator OTHER

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

  lead OTHER

Principal Investigators

• Jesús Álvarez-García, MD, PhD · Ramón y Cajal University Hospital, Madrid, Spain

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-29

Primary Completion

2027-06-30

Completion

2027-08-31

FDA Device

Yes

Countries

• Spain

Study Locations