Acute Heart Failure (AHF)ReDS-LATAM HFNCT07600398
ReDS-Guided Decongestion in Acute Heart Failure (ReDS-LATAM HF)
A study testing Remote Dielectric Sensing (ReDS) and Standar of care in people with Acute Heart Failure (AHF), run by Instituto Cardiovascular de Buenos Aires at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Heart Failure (AHF)
- What is being tested?
- Remote Dielectric Sensing (ReDS) and Standar of care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteArgentina
- Study dates
- 1 May 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Instituto Cardiovascular de Buenos Aires
Buenos Aires, Buenos Aires, 1428
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Acute Heart Failure (AHF)
- Being tested
- Remote Dielectric Sensing (ReDS), Standar of care
- Keywords
- acute heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standar of careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standar of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 (±5) days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 May 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Cardiovascular de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucrecia Maria Burgos, Instituto Cardiovascular de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600398
- Sponsor's protocol ID
- ReDS-LATAM HF
- Acronym
- ReDS-LATAM HF
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38430084
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReDS-LATAM HF: A Randomized Trial of Remote Dielectric Sensing-Guided Decongestion in Acute Heart Failure
- ClinicalTrials.gov ID
- NCT07600398
- Acronym / sponsor ID
- ReDS-LATAM HF / ReDS-LATAM HF
- Conditions
- Acute Heart Failure (AHF)
- Keywords
- acute heart failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Instituto Cardiovascular de Buenos AiresUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReDS-Guided Decongestion Strategy | Experimental | Device: Remote Dielectric Sensing (ReDS), Other: Standar of careParticipants 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. |
| Standar of care | Active comparator | Other: Standar of careParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ReDS-Guided Decongestion Strategy |
| Standar of careStandard 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. | Other | ReDS-Guided Decongestion Strategy, Standar of care |
Primary outcome
Composite of all-cause mortality, heart failure rehospitalization, or unplanned heart failure visit
Time frame: Within 30 (±5) days after hospital discharge
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 38430084Alvarez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Dielectric Sensing (ReDS) and Standar of care in people with Acute Heart Failure (AHF), run by Instituto Cardiovascular de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality, heart failure rehospitalization, or unplanned heart failure visit (time frame: Within 30 (±5) days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07600398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.