Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care
Effect of Non-Invasive Lung Fluid Monitoring Using ReDS Technology for Heart Failure Management in Primary Care Settings: A Randomized Controlled Trial
Linkoeping University
330 participants
Apr 16, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- 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.
Interventions
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.
Locations(1)
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NCT06734065