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

NCT07600398 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2026-05-20

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • Instituto Cardiovascular de Buenos Aires

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-06-01
Completion
2027-06-01

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07600398 on ClinicalTrials.gov