ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure (ReDS-SAFE HF 2)

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure: the ReDS-SAFE HF II Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Heart Failure (AHF); Heart Failure (for Example, Fluid Overload); Heart Failure Hospitalization
• Intervention / Treatment: Device: Remote Dielectric Sensing System; Device: Blinded ReDS data

• Study Type: Interventional
• Enrollment (Estimated): 1014
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesús Álvarez-García, MD, PhD; Phone Number: 34 667495661; Email: jalvarezg82@gmail.com
• Study Contact Backup: Name: Cristina Rey Iborra, BSN; Email: creyi@salud.madrid.org

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital del Mar
    • Contact: Sandra Valdivielso Moré, MD, PhD; Phone Number: 34 932 48 30 00; Email: svaldivielso@hmar.cat
  • Barcelona, Spain
    • Not yet recruiting
    • Hospital Clinic
    • Contact: Eduard Solé González, MD, PhD; Phone Number: 34 932 27 54 00; Email: edsole@clinic.cat
  • Barcelona, Spain
    • Recruiting
    • Bellvitge University Hospital
    • Contact: Herminio Morillas Climent, MD, PhD; Phone Number: 34 932 60 75 00; Email: herminiomorillas@bellvitgehospital.cat
  • Barcelona, Spain
    • Not yet recruiting
    • Vall d'Hebron University Hospital
    • Contact: Toni Soriano Colomé, MD, PhD; Phone Number: 34 934 89 30 00; Email: tonisorianocolome@gmail.com
  • Barcelona, Spain
    • Not yet recruiting
    • Arnau de Vilanova University Hospital
    • Contact: Ramón Bascompte Claret, MD, PhD; Phone Number: 34 961 97 60 00; Email: rbascompte.lleida.ics@gencat.cat
  • Córdoba, Spain
    • Recruiting
    • Reina Sofia University Hospital
    • Contact: Manuel Pérez Anguita, MD, PhD; Phone Number: 34 911 91 40 00; Email: manuelp.anguita.sspa@juntadeandalucia.es
  • Girona, Spain
    • Recruiting
    • Dr Josep Trueta University Hospital
    • Contact: Aleix Tort Pal, MD, PhD; Phone Number: 34 972 94 02 00; Email: afort.girona.ics@gencat.cat
  • Madrid, Spain
    • Recruiting
    • La Paz University Hospital
    • Contact: Angel Iniesta Manjavacas, MD, PhD; Phone Number: 34 917 27 70 00; Email: a.m.iniesta84@gmail.com
  • Madrid, Spain
    • Recruiting
    • 12 de Octubre University Hospital
    • Contact: Laura Morán Fernandez, MD; Phone Number: 34 913 90 80 00; Email: lauramoranfernandez@gmail.com
  • Madrid, Spain
    • Not yet recruiting
    • Clínico San Carlos University Hospital
    • Contact: Josebe Goirigolzarri Artaza, MD, PhD; Phone Number: 34 913 30 30 00; Email: josebegoiri@gmail.com
  • Madrid, Spain
    • Not yet recruiting
    • Fundacion Jimenez Diaz University Hospital
    • Contact: Mikel Taibo Urquía, MD, PhD; Phone Number: 34 915 50 48 00; Email: Mikel.taibo@fjd.es
  • Madrid, Spain
    • Not yet recruiting
    • Gregorio Marañón University Hospital
    • Contact: Zorba Blázquez Bermejo, MD, PhD; Phone Number: 34 915 86 80 00; Email: zorbablbe@gmail.com
  • Madrid, Spain
    • Not yet recruiting
    • La Princesa University Hospital
    • Contact: Pablo Díez Villanueva, MD, PhD; Phone Number: 34 915 20 22 00; Email: pdiezvillanueva@secardiologia.es
  • Madrid, Spain
    • Recruiting
    • Puerta de Hierro Majadahonda University Hospital
    • Contact: Mercedes Rivas-Lasarte, MD, PhD; Phone Number: 34 911 91 60 00; Email: rivaslasarte@gmail.com
  • Murcia, Spain
    • Not yet recruiting
    • Virgen de la Arrixaca
    • Contact: Noelia Fernández Villa, MD; Phone Number: 34 968 36 95 00; Email: noelia.fernandez7@um.es
  • Málaga, Spain
    • Recruiting
    • Virgen de la Victoria University Hospital
    • Contact: Ainhoa Robles Mezcua, MD, PhD; Phone Number: 34 951 03 20 00; Email: ainhoa.mezcua@gmail.com
  • Salamanca, Spain
    • Not yet recruiting
    • Complejo Asistencial Universitario de Salamanca
    • Contact: David González Calle, MD, PhD; Phone Number: 34 923 29 11 00; Email: davidgonzalezcalle@gmail.com
  • Sant Joan Despí, Spain
    • Recruiting
    • San Juan Despí Moisès Broggi Hospital
    • Contact: Román Freixa Pamies, MD, PhD; Email: roman.freixa@sanitatintegral.org
  • Santander, Spain
    • Not yet recruiting
    • Marqués de Valdecilla University Hospital
    • Contact: Gonzalo Martín Gorrria, MD; Phone Number: 34 942 20 25 20; Email: gonzalo.martin@scsalud.es
  • Santiago de Compostela, Spain
    • Recruiting
    • Complejo Hospitalario Universitario de Santiago
    • Contact: Inés Gómez Otero, MD, PhD; Phone Number: 34 981 95 00 00; Email: mgo300971@gmail.com
  • Seville, Spain
    • Not yet recruiting
    • Virgen de la Macarena University Hospital
    • Contact: Alejandro Recio Mayoral, MD, PhD; Phone Number: 34 955 00 80 00; Email: recioalejandro@yahoo.es
  • Tarragona, Spain
    • Not yet recruiting
    • Sant Joan XXIII University Hospital
    • Contact: María Ferrero Guillem, MD; Phone Number: 34 977 29 58 00; Email: mariaferrero23@gmail.com
  • Toledo, Spain
    • Not yet recruiting
    • Hospital General Universitario de Toledo
    • Contact: Marta Flores Hernáne¡, MD; Phone Number: 34 925 26 92 00; Email: flores13marta@gmail.com
  • Valencia, Spain
    • Not yet recruiting
    • Clínico University Hospital
    • Contact: Julio Núñez Villota, MD, PhD; Phone Number: 34 961 97 35 00; Email: yulnunez@gmail.com
  • Madrid
    • Madrid, Madrid, Spain, 28034
      • Recruiting
      • Ramon y Cajal University Hospital
      • Contact: Cristina Rey Iborra, BSN; Email: creyi@salud.madrid.org
      • Contact: Jesús Álvarez-García, MD, PhD; Phone Number: 34 677495661; Email: jalvarezg82@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ReDS-guided strategy; Each day, the clinician responsible for the patient will have access to the ReDS value and will adjust the treatment according to the study's diuretic protocol. The responsible physician can discharge the patient if the clinical stability criteria are met, and the ReDS value is below 35% and a relative reduction of 10% or more from the admission ReDS value has been achieved (i.e. a patient admitted with a ReDS value of 36% should be discharged with a ReDS of 32% at least; or a patient admitted with a ReDS of 34% should be discharged with a ReDS of 31% at least). If the ReDS criteria are not met, the patient should remain hospitalized for another day until these conditions are met. Clinical stability is defined as the presence of at least 2 of the following 3 conditions: i) discharge weight lower than admission weight, ii) at least a 30% reduction in natriuretic peptide from admission, and iii) a score <2 in the Orthoedema score	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.
Sham Comparator: Usual clinical practice strategy; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From randomization to the end of follow-up at 1 month after hospitalization 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).	From randomization to the end of follow-up at 1 month after hospitalization discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-efficacy outcome measure	Length of stay and cost of ReDS device	Length of stay of index admission

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Collaborators: Hospital General Universitario Gregorio Marañon; Hospital Clinic of Barcelona; Hospital Universitario Ramon y Cajal; Hospital Arnau de Vilanova; Salamanca University Hospital; Hospital del Mar; Hospital Universitario Virgen Macarena; Hospital Universitari de Bellvitge; Hospital Universitario Virgen de la Arrixaca; Hospital Universitario 12 de Octubre; Puerta de Hierro University Hospital; Hospital Universitario Reina Sofia de Cordoba; Hospital Universitario Fundación Jiménez Díaz; Hospital San Carlos, Madrid; Hospital Universitario La Paz; Hospital Vall d'Hebron; Hospital Universitario Marqués de Valdecilla; Hospital Universitario Virgen de la Victoria; Complejo Hospitalario Universitario de Santiago; Hospital Clínico Universitario de Valencia; Complejo Hospitalario Toledo; Hospital Sant Joan Despí Moisès Broggi; Centro Nacional de Investigaciones Cardiovasculares Carlos III; Joan XXIII University Hospital; University Hospital of Girona Dr. Josep Trueta; La Princesa University Hospital Madrid
• Investigators: Principal Investigator: Jesús Álvarez-García, MD, PhD, Ramón y Cajal University Hospital, Madrid, Spain

Publications and helpful links

General Publications

• Lala A, Barghash MH, Giustino G, Alvarez-Garcia J, Konje S, Parikh A, Ullman J, Keith B, Donehey J, Mitter SS, Trivieri MG, Contreras JP, Burkhoff D, Moss N, Mancini DM, Pinney SP. Early use of remote dielectric sensing after hospitalization to reduce heart failure readmissions. ESC Heart Fail. 2021 Apr;8(2):1047-1054. doi: 10.1002/ehf2.13026. Epub 2020 Dec 18.
• Alvarez-Garcia J, Lala A, Rivas-Lasarte M, De Rueda C, Brunjes D, Lozano-Jimenez S, Garcia-Sebastian C, Mitter S, Remior P, Jimenez-Blanco Bravo M, Del Prado S, Barghash M, Gonzalez-Ferrer E, Ullman J, Cobo M, Segovia-Cubero J, Zamorano JL, Pinney SP, Mancini D. Remote Dielectric Sensing Before and After Discharge in Patients With ADHF: The ReDS-SAFE HF Trial. JACC Heart Fail. 2024 Apr;12(4):695-706. doi: 10.1016/j.jchf.2024.01.002. Epub 2024 Feb 28.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Heart failure; Randomized Clinical Trial; Congestion; Fluid Overload; ReDS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Heart Failure; Edema
• Other Study ID Numbers: 208/24; PI24/01541 (Other Grant/Funding Number: Carlos III Institute of Health (Ministry of Science, Innovation and University of Spain)); SEC/FEC-INV-CLI 24/17 (Other Grant/Funding Number: Spanish Society of Cardiology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes