Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care

Not Applicable

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06734065
• Lead Sponsor: Linkoeping University

Brief 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.

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 Timeline

• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-16
• Status Verified: 2025-04
• Study Start: 2025-04-16
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2030-07
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total number of acute healthcare visits for heart failure	1 month, 3 months and 6 months
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 NT-proBNP/BNP levels	Baseline, 3 months and 6 months
Changes in the remote dielectric sensing (ReDS) values	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.
Changes in the 12-item Kansas City Cardiomyopathy Questionnaire scores	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.
Changes in the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) scores	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.
Changes in the heart failrue self-care behaviour scores	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).

Trial Locations

Locations (1)

Primary care center Centrum Flen; 🇸🇪 Flen, Sweden