Heart FailureLiLAC-HFNCT06734065
Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care
A study testing ReDS-guided heart failure management program in people with Heart Failure, run by Linkoeping University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- ReDS-guided heart failure management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSweden
- Study dates
- 16 Apr 2025to Dec 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Primary care center Centrum Flen
Flen
Naoko Perkiö Kato, RN, PhD, +46 11-36 31 17, naoko.perkio.kato@liu.se
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Conditions
- Heart Failure
- Being tested
- ReDS-guided heart failure management program
- Keywords
- Heart failure, Primary care, Nursing, Monitoring, Self-care, Community
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReDS-guided heart failure management programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care group | No intervention | Patients in the usual care group will receive usual care. |
| ReDS-guided heart failure management group | Experimental | Not described Receives: Behavioral: ReDS-guided heart failure management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death
Measured: 3 months
Secondary outcomes (9)
Total number of acute healthcare visits for heart failure
Measured: 1 month, 3 months and 6 months
Total number of unplanned hospitalisations for heart failure
Measured: 1 month, 3 months and 6 months
Total number of all-cause death
Measured: 1 month, 3 months and 6 months
Number of days alive out of hospital
Measured: 1 month, 3 months and 6 months
Changes in NT-proBNP/BNP levels
Measured: Baseline, 3 months and 6 months
Changes in the remote dielectric sensing (ReDS) values
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.
Measured: Baseline, 3 months and 6 months
Changes in the 12-item Kansas City Cardiomyopathy Questionnaire scores
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.
Measured: Baseline, 1 month, 3 months and 6 months
Changes in the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) scores
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.
Measured: Baseline, 1 month, 3 months and 6 months
Changes in the heart failrue self-care behaviour scores
The European Heart Failure Self-Care Behaviour Scale (EHFScBS) is a 9-item scale, with higher scores indicating poorer self-care (range: 9-45).
Measured: Baseline, 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start16 Apr 2025
- Primary completionJul 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Naoko Perkiö Kato, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734065
- Sponsor's protocol ID
- Dnr 2024-05565-01
- Acronym
- LiLAC-HF
- Status last verified
- Apr 2025
- First submitted
- 27 Nov 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Invasive Lung Fluid Monitoring Using ReDS Technology for Heart Failure Management in Primary Care Settings: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06734065
- Acronym / sponsor ID
- LiLAC-HF / Dnr 2024-05565-01
- Conditions
- Heart Failure
- Keywords
- Heart failure, Primary care, Nursing, Monitoring, Self-care, Community
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 16 Dec 2024 (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.
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.
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:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care group | No intervention | –Patients in the usual care group will receive usual care. |
| ReDS-guided heart failure management group | Experimental | Behavioral: ReDS-guided heart failure management program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| ReDS-guided heart failure management programRemote 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. | Behavioural | ReDS-guided heart failure management group |
Primary outcome
Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death
Time frame: 3 months
9 secondary outcomes
Total number of acute healthcare visits for heart failure
Time frame: 1 month, 3 months and 6 months
Total number of unplanned hospitalisations for heart failure
Time frame: 1 month, 3 months and 6 months
Total number of all-cause death
Time frame: 1 month, 3 months and 6 months
Number of days alive out of hospital
Time frame: 1 month, 3 months and 6 months
Changes in NT-proBNP/BNP levels
Time frame: Baseline, 3 months and 6 months
Changes in the remote dielectric sensing (ReDS) values
Time frame: Baseline, 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
Changes in the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) scores
Time frame: 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
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 27 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReDS-guided heart failure management program in people with Heart Failure, run by Linkoeping University at 1 site in Sweden.
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 4 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: looking for participants now, as of the sponsor's last update on 27 Apr 2025. 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 Sweden. 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?
Contact Naoko Perkiö Kato, PhD (+46 (0)11-36 31 17, naoko.perkio.kato@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2025.