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ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT07484009•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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).
•2. NT-proBNP greater than 1000 pg/L or BNP greater than 300 pg/L upon admission.

Exclusion Criteria

•1. 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.
•2. Patients requiring inotropes (levosimendan is allowed) or vasopressors upon admission, with mechanical support, or heart transplant recipients.
•3. Any malformation or variant affecting the right lung anatomy (e.g., a pacemaker).
•4. 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.
•5. Chronic kidney disease with a GFR \<20 or on hemodialysis.
•6. Life expectancy less than 12 months due to non-cardiological origin.
•7. Participation in another clinical trial with intervention.

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

Key Dates

Start Date

January 29, 2026

Primary Completion Date

June 30, 2027

Completion Date

August 31, 2027

Last Updated

March 19, 2026

Enrollment

1,014

ESTIMATED participants

Conditions

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

Interventions

Remote Dielectric Sensing System

DEVICE

Blinded ReDS data

DEVICE

Contacts

Jesús Álvarez-García, MD, PhD

CONTACT

34 667495661 jalvarezg82@gmail.com

Cristina Rey Iborra, BSN

CONTACT

creyi@salud.madrid.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

Inclusion Criteria

Exclusion Criteria

Digoxin After Acute Heart Failure

Evaluating the Effects of Nitroglycerin on Heart Function and Urinary Output in Patients With Acute Heart Failure

Teach-Back Discharge Education to Improve Self-Care and Reduce 30-Day Readmissions in Heart Failure Patients

A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients