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ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

Study acronym: ReDS-SAFE HF 2
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07484009
Lead Sponsor Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators: Hospital Universitario Ramon y Cajal, Hospital Universitario 12 de Octubre, Hospital San Carlos, Madrid, Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario La Paz, Hospital General Universitario Gregorio Marañon, Hospital Clinic of Barcelona, Hospital Vall d'Hebron, Hospital Universitari de Bellvitge, Hospital del Mar, Hospital Sant Joan Despí Moisès Broggi, Hospital Arnau de Vilanova, Hospital Universitario Virgen de la Arrixaca, Complejo Hospitalario Universitario de Santiago, Salamanca University Hospital, Complejo Hospitalario Toledo, Hospital Universitario Virgen Macarena, Hospital Universitario Reina Sofia de Cordoba, Hospital Universitario Virgen de la Victoria, Hospital Universitario Marqués de Valdecilla, Hospital Clínico Universitario de Valencia, Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III, Puerta de Hierro University Hospital, La Princesa University Hospital Madrid, University Hospital of Girona Dr. Josep Trueta, Joan XXIII University Hospital
Conditions
(from sponsor)		 Acute Heart Failure (AHF), Heart Failure (for Example, Fluid Overload), Heart Failure Hospitalization
Related terms Edema, Heart Failure
Enrollment 1,014 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov