ReDS-Guided Decongestion in Acute Heart Failure (ReDS-LATAM HF) (ReDS-LATAM HF)

ReDS-LATAM HF: A Randomized Trial of Remote Dielectric Sensing-Guided Decongestion in Acute Heart Failure

Heart failure (HF) is a leading cause of hospitalization, with high rates of early readmission largely driven by residual congestion at discharge. Conventional methods to assess congestion are often imprecise and may fail to guide optimal decongestive therapy.

Remote Dielectric Sensing (ReDS) is a non-invasive technology that provides a rapid and objective estimate of lung fluid content. This study aims to evaluate whether a ReDS-guided decongestion strategy improves clinical outcomes compared with standard care in patients hospitalized for acute heart failure.

In this randomized controlled trial, patients will be assigned 1:1 to a ReDS-guided strategy or standard care. ReDS measurements will be performed in both groups but will only guide treatment in the intervention arm.

The primary endpoint is a composite of all-cause mortality, heart failure rehospitalization, or unplanned HF visit within 30 (±5) days after discharge.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Heart Failure (AHF)
• Intervention / Treatment: Device: Remote Dielectric Sensing (ReDS); Other: Standar of care

Detailed Description

Congestion is the main driver of hospitalization and adverse outcomes in acute heart failure (AHF). Residual congestion at discharge is common and associated with increased risk of early rehospitalization and mortality. However, current approaches to assess congestion rely on clinical judgment and indirect markers, which may be insufficient to guide therapy.

Remote Dielectric Sensing (ReDS) is a non-invasive technology that quantifies lung fluid content within seconds. It provides an objective measurement that has been validated against imaging and invasive hemodynamic parameters.

The ReDS-LATAM HF study is a pragmatic, single-center, randomized controlled trial designed to assess whether a ReDS-guided strategy improves early outcomes in patients hospitalized with AHF.

Patients will be randomized 1:1 to either a ReDS-guided strategy, in which daily measurements are used to adjust diuretic therapy according to a predefined protocol, or to standard care based on usual clinical practice. ReDS measurements will be obtained in both groups, but values will be blinded in the control arm.

The primary outcome is a composite of all-cause mortality, heart failure rehospitalization, or unplanned HF visit within 30 (±5) days after discharge. Secondary analyses will include individual components of the primary endpoint, changes in biomarkers, and safety outcomes.

This study also aims to evaluate the feasibility of implementing this technology in a real-world Latin American setting.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Buenos Aires, Buenos Aires, Argentina, 1428
      • Instituto Cardiovascular de Buenos Aires

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age ≥21 years
• Hospitalization for acute heart failure with signs of congestion within 48 hours of admission
• Elevated natriuretic peptides (NT-proBNP >1000 pg/mL or BNP equivalent)
• Ability to provide informed consent

Exclusion Criteria:

• Need for inotropes, vasopressors, or mechanical circulatory support at enrollment Heart transplant recipient Mechanical ventilation at enrollment Conditions that prevent reliable ReDS measurement Planned cardiac surgery or intervention during the study period Severe renal dysfunction (eGFR <15 mL/min/1.73 m² or dialysis) Life expectancy <3 months Inability to complete follow-up Participation in another interventional trial Any condition that may compromise safety or study integrity

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 Decongestion Strategy; Participants assigned to this arm will undergo daily Remote Dielectric Sensing (ReDS) measurements during hospitalization. ReDS values will be available to the treating physician and used to guide adjustment of diuretic therapy according to a predefined protocol aimed at achieving effective decongestion while avoiding volume depletion. Treatment decisions, including diuretic dosing and escalation, will be based on ReDS thresholds in combination with clinical judgment. Patients will be discharged based on clinical stability criteria, incorporating ReDS values as part of the decongestion assessment.	Device: Remote Dielectric Sensing (ReDS); Remote Dielectric Sensing (ReDS) is a non-invasive device that estimates lung fluid content by measuring the dielectric properties of thoracic tissues. The system consists of wearable sensors positioned on the anterior and posterior chest, providing a quantitative measurement within approximately 45 seconds. In this study, ReDS measurements will be performed daily during hospitalization. In the intervention arm, results will be available to the treating physician and used to guide diuretic therapy according to predefined thresholds. In the control arm, measurements will be performed but results will remain blinded and will not influence clinical decision-making.; Other: Standar of care; Standard care consists of treatment based on routine clinical assessment, including physical examination, laboratory parameters, and institutional protocols. Diuretic therapy and other treatments will be adjusted according to the treating physician's clinical judgment, without access to ReDS measurements.
Active Comparator: Standar of care; Participants assigned to this arm will receive standard care based on routine clinical assessment, including physical examination, laboratory parameters, and usual institutional practice. Remote Dielectric Sensing (ReDS) measurements will be performed daily during hospitalization; however, the results will be blinded and not available to the treating physician. Treatment decisions, including diuretic therapy, will be made according to clinical judgment without access to ReDS data.	Other: Standar of care; Standard care consists of treatment based on routine clinical assessment, including physical examination, laboratory parameters, and institutional protocols. Diuretic therapy and other treatments will be adjusted according to the treating physician's clinical judgment, without access to ReDS measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of all-cause mortality, heart failure rehospitalization, or unplanned heart failure visit	Time to first occurrence of a composite endpoint including all-cause mortality, rehospitalization for heart failure (defined as an unplanned hospital admission >24 hours requiring intensification of heart failure therapy), or an unplanned visit for heart failure (emergency department or urgent outpatient visit requiring treatment escalation) within 30 (±5) days after discharge.	Within 30 (±5) days after hospital discharge

Collaborators and Investigators

• Sponsor: Instituto Cardiovascular de Buenos Aires

Publications and helpful links

General Publications

• 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): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: acute heart failure
• Other Study ID Numbers: ReDS-LATAM HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No