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.
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.
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.
Any malformation or variant affecting the right lung anatomy (e.g., a pacemaker).
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.
Parallel
Remote Dielectric Sensing System
DeviceThe 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
DeviceThe 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.
Number of participants with an efficacy event at 1 month after discharge
The primary outcome measure is the combined event rate of all-cause mortality, HF readmission, and/or unexpected HF visits requiring diuretic adjustment at 1 month after discharge
Number of participant with a safety event at 1 month after discharge
The primary outcome measure is the combined event rate of symptomatic systolic hypotension (\<90 mmHg), electrolyte imbalances (potassium below 3 or above 5.5 meq/L), and/or worsening of renal function compared to the baseline visit at the first post-discharge outpatient visit (at least 50% reduction in glomerular filtration rate).
Cost-efficacy outcome measure
Length of stay and cost of ReDS device
Click on the lead sponsor to view all of their trials.
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead sponsor
Hospital Universitario Ramon y Cajal
Sponsor institution
Hospital Universitario Ramon y Cajal
Collaborator
Hospital Universitario 12 de Octubre
Collaborator
Hospital San Carlos, Madrid
Collaborator
Hospital Universitario Fundación Jiménez Díaz
Collaborator
Hospital Universitario La Paz
Collaborator
Hospital General Universitario Gregorio Marañon
Collaborator
Hospital Clinic of Barcelona
Collaborator
Hospital Vall d'Hebron
Collaborator
Hospital Universitari de Bellvitge
Collaborator
Hospital del Mar
Collaborator
Hospital Sant Joan Despí Moisès Broggi
Collaborator
Hospital Arnau de Vilanova
Collaborator
Hospital Universitario Virgen de la Arrixaca
Collaborator
Complejo Hospitalario Universitario de Santiago
Collaborator
Salamanca University Hospital
Collaborator
Complejo Hospitalario Toledo
Collaborator
Hospital Universitario Virgen Macarena
Collaborator
Hospital Universitario Reina Sofia de Cordoba
Collaborator
Hospital Universitario Virgen de la Victoria
Collaborator
Hospital Universitario Marqués de Valdecilla
Collaborator
Hospital Clínico Universitario de Valencia
Collaborator
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Collaborator
Puerta de Hierro University Hospital
Collaborator
La Princesa University Hospital Madrid
Collaborator
University Hospital of Girona Dr. Josep Trueta
Collaborator
Joan XXIII University Hospital
Collaborator
