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

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: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: ReDS-guided heart failure management program

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: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naoko Perkiö Kato, PhD; Phone Number: +46 (0)11-36 31 17; Email: naoko.perkio.kato@liu.se

Study Locations

• Sweden
  • Flen, Sweden
    • Recruiting
    • Primary care center Centrum Flen
    • Contact: Naoko Perkiö Kato, RN, PhD; Phone Number: +46 11-36 31 17; Email: naoko.perkio.kato@liu.se

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of unplanned hospitalisations for heart failure		1 month, 3 months and 6 months
Total number of all-cause death		1 month, 3 months and 6 months
Number of days alive out of hospital		1 month, 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.	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).	Baseline, 1 month, 3 months and 6 months
Total number of acute healthcare visits for heart failure		1 month, 3 months and 6 months
Changes in NT-proBNP/BNP levels		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.	Baseline, 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.	Baseline, 1 month, 3 months and 6 months

Other Outcome Measures

Outcome Measure	Time Frame
Healthcare costs	1 month, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Linkoeping University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Monitoring; Primary care; Heart failure; Nursing; Self-care; Community
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID 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