NCT07484009

Brief 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:

  • 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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,014

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jan 2026

Geographic Reach
1 country

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jan 2026Aug 2027

Study Start

First participant enrolled

January 29, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 6, 2026

Last Update Submit

March 16, 2026

Conditions

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

Keywords

Heart failureCongestionReDSFluid OverloadRandomized Clinical Trial

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Cost-efficacy outcome measure

    Length of stay of index admission

Study Arms (2)

ReDS-guided strategy

EXPERIMENTAL

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

Usual clinical practice strategy

SHAM COMPARATOR

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

Interventions

Remote Dielectric Sensing SystemDEVICE

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.

ReDS-guided strategy
Blinded ReDS dataDEVICE

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.

Usual clinical practice strategy

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsA third of females of total will be required
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Chronic kidney disease with a GFR \<20 or on hemodialysis.
  • Life expectancy less than 12 months due to non-cardiological origin.
  • Participation in another clinical trial with intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Ramón y Cajal University Hospital

Madrid, Madrid, 28034, Spain

RECRUITING

Arnau de Vilanova University Hospital

Barcelona, Spain

NOT YET RECRUITING

Bellvitge University Hospital

Barcelona, Spain

RECRUITING

Hospital Clinic

Barcelona, Spain

NOT YET RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Vall d'Hebrón University Hospital

Barcelona, Spain

NOT YET RECRUITING

Reina Sofía University Hospital

Córdoba, Spain

RECRUITING

Dr Josep Trueta University Hospital

Girona, Spain

RECRUITING

12 de Octubre University Hospital

Madrid, Spain

RECRUITING

Clínico San Carlos University Hospital

Madrid, Spain

NOT YET RECRUITING

Fundación Jiménez Díaz University Hospital

Madrid, Spain

NOT YET RECRUITING

Gregorio Marañón University Hospital

Madrid, Spain

NOT YET RECRUITING

La Paz University Hospital

Madrid, Spain

RECRUITING

La Princesa University Hospital

Madrid, Spain

NOT YET RECRUITING

Puerta de Hierro Majadahonda University Hospital

Madrid, Spain

RECRUITING

Virgen de la Victoria University Hospital

Málaga, Spain

RECRUITING

Virgen de la Arrixaca

Murcia, Spain

NOT YET RECRUITING

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

NOT YET RECRUITING

San Juan Despí Moisès Broggi Hospital

Sant Joan Despí, Spain

RECRUITING

Marqués de Valdecilla University Hospital

Santander, Spain

NOT YET RECRUITING

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

RECRUITING

Virgen de la Macarena University Hospital

Seville, Spain

NOT YET RECRUITING

Sant Joan XXIII University Hospital

Tarragona, Spain

NOT YET RECRUITING

Hospital General Universitario de Toledo

Toledo, Spain

NOT YET RECRUITING

Clínico University Hospital

Valencia, Spain

NOT YET RECRUITING

Related Publications (2)

  • 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.

    PMID: 33336881BACKGROUND

  • 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.

    PMID: 38430084BACKGROUND

MeSH Terms

Conditions

Heart FailureEdema

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jesús Álvarez-García, MD, PhD

    Ramón y Cajal University Hospital, Madrid, Spain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesús Álvarez-García, MD, PhD

CONTACT

34 667495661jalvarezg82@gmail.com

Cristina Rey Iborra, BSN

CONTACT

creyi@salud.madrid.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Heart Failure Section

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 19, 2026

Study Start

January 29, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

ES(25)