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

NCT07600398 | Active Not Recruiting

• 1 other identifier: ReDS-LATAM HF
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Heart Failure (AHF)

Keywords

acute heart failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ReDS-Guided Decongestion Strategy

EXPERIMENTAL

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); Other: Standar of care

Standar of care

ACTIVE COMPARATOR

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

Interventions

Remote Dielectric Sensing (ReDS) DEVICE

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.

ReDS-Guided Decongestion Strategy

Standar of care OTHER

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.

ReDS-Guided Decongestion Strategy; Standar of care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Cardiovascular de Buenos Aires: lead

Study Sites (1)

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Buenos Aires, 1428, Argentina

Location

Related Publications (1)

• 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: 38430084 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. Participants are unaware of treatment allocation. Treating physicians are not blinded, as ReDS measurements are used to guide therapy in the intervention group. In the control group, ReDS measurements are performed but results are not disclosed to the treating team. Clinical events will be adjudicated by independent outcome assessors blinded to treatment allocation and ReDS values.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)