Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care (LiLAC-HF)

April 23, 2025 updated by: Naoko Perkiö Kato, Linkoeping University

Effect of Non-Invasive Lung Fluid Monitoring Using ReDS Technology for Heart Failure Management in Primary Care Settings: A Randomized Controlled Trial

Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. This randomized controlled trial aims to evaluate the effectiveness and processes of the ReDS-guided heart failure management program in primary care settings for patients with heart failure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. Our newly developed ReDS-guided heart failure management program, led by nurses, incorporates algorithms for a follow-up schedule, diuretic adjustments, and symptom monitoring.

The specific aims of the study are:

  1. To examine whether the program decreases the number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death in patients with heart failure.
  2. To evaluate the intervention processes and explore barriers to and facilitators for the implementation of the program.

This is a multicentre 1:1 randomised controlled clinical trial with a 6-month follow-up. Study participants will be patients with diagnosed with heart failure. The primary outcome will be the total number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisation, and all-cause death at 3 months. Secondary outcomes will include health-related quality of life, self-care behaviour, and healthcare cost. Throughout the randomised controlled trial, a process evaluation will be conducted to assess the fidelity, dose, and reach of the intervention program. Additionally, we will explore both barriers and facilitators for program implementation among study patients and healthcare professionals.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Flen, Sweden
        • Recruiting
        • Primary care center Centrum Flen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years, there is no upper age limit
  • Diagnosed with heart failure regardless of left ventricular ejection fraction
  • Having New York Heart Association (NYHA) Class III/IV irrespective of prior hospitalisation for heart failure, or NYHA II with a history of at least one hospitalisation for heart failure within the previous 12 months
  • Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) within 12 months: (a) ≥450 pg/ml for patients under 50 years; (b) ≥900 pg/ml for patients aged 50-75 years; (c) ≥1800 pg/ml for patients over 75 years.

Exclusion Criteria:

  • NYHA I
  • Life expectancy <6 months
  • Physical characteristics that prevented use of the ReDS (body mass index < 22 or >39, and height less than 155 cm or higher than 195 cm)
  • Implantation of a left ventricular assist device or cardiac transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual care group
Patients in the usual care group will receive usual care.
Experimental: ReDS-guided heart failure management group
Behavioral: ReDS-guided heart failure management program

Remote dielectric sensing (ReDS) system (Sensible Medical Innovations Ltd., Netanya, Israel) is a novel electromagnetic energy-based technology that accurately quantifies changes in lung fluid concentration non-invasively.

Patients in the intervention group will receive a three-month, ReDS-guided heart failure management program in addition to usual care.

The program, led by nurses, will integrate algorithms for diuretic use, a structured follow-up schedule, and self-care support tailored to pulmonary fluid levels assessed by ReDS.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death
Time Frame: 3 months
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total number of unplanned hospitalisations for heart failure
Time Frame: 1 month, 3 months and 6 months
1 month, 3 months and 6 months
Total number of all-cause death
Time Frame: 1 month, 3 months and 6 months
1 month, 3 months and 6 months
Number of days alive out of hospital
Time Frame: 1 month, 3 months and 6 months
1 month, 3 months and 6 months
Changes in the 12-item Kansas City Cardiomyopathy Questionnaire scores
Time Frame: Baseline, 1 month, 3 months and 6 months
The 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated instrument for quantitatively measuring health status for patients with heart failure. It contains four domains: physical limitation, symptom frequency, quality of life, and social limitations. The KCCQ-12 generates both summary and domain scores ranging from 0 to 100, where 0 represents the worst and 100 the best possible health status.
Baseline, 1 month, 3 months and 6 months
Changes in the heart failrue self-care behaviour scores
Time Frame: Baseline, 1 month, 3 months and 6 months
The European Heart Failure Self-Care Behaviour Scale (EHFScBS) is a 9-item scale, with higher scores indicating poorer self-care (range: 9-45).
Baseline, 1 month, 3 months and 6 months
Total number of acute healthcare visits for heart failure
Time Frame: 1 month, 3 months and 6 months
1 month, 3 months and 6 months
Changes in NT-proBNP/BNP levels
Time Frame: Baseline, 3 months and 6 months
Baseline, 3 months and 6 months
Changes in the remote dielectric sensing (ReDS) values
Time Frame: Baseline, 3 months and 6 months
The remote dielectric sensing (ReDS) system (Sensible Medical Innovations Ltd., Netanya, Israel) is a novel electromagnetic energy-based technology that accurately quantifies lung fluid content non-invasively. Normal ReDS values range from 20% to 35%. Values above 35% indicate hypervolemia, while values below 20% suggest dehydration.
Baseline, 3 months and 6 months
Changes in the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) scores
Time Frame: Baseline, 1 month, 3 months and 6 months
The 5-level EuroQol-5 Dimension version (EQ-5D-5L) assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels, with higher scores indicating better health-related quality of life.
Baseline, 1 month, 3 months and 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Healthcare costs
Time Frame: 1 month, 3 months and 6 months
1 month, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linkoeping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dnr 2024-05565-01

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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