Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ReDS-guided heart failure management program.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Non-Invasive Lung Fluid Monitoring Using ReDS Technology for Heart Failure Management in Primary Care Settings: A Randomized Controlled Trial
Overview
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.
Interventions
- 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 p
Primary outcome measures
- Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death [Time frame: 3 months]
Secondary outcome measures (9)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Sweden · 1 center
- Primary care center Centrum Flen — Flen
Identifiers
NCT: NCT06734065 · Dnr 2024-05565-01