Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care
NCT ID: NCT06734065
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
330 participants
INTERVENTIONAL
2025-04-16
2030-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Usual care group
Patients in the usual care group will receive usual care.
No interventions assigned to this group
ReDS-guided heart failure management group
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Naoko Perkiö Kato
Associate Professor
Locations
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Primary care center Centrum Flen
Flen, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Dnr 2024-05565-01
Identifier Type: -
Identifier Source: org_study_id
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