Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLinkoeping University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ReDS-guided heart failure management program
BehavioralRemote 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.
Treatment groups
330 Participants
are divided into 2 treatment groupsGroup A: Usual care groupNo intervention 0 interventions
Group B: ReDS-guided heart failure management groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death
Time frame
3 monthsSecondary outcomes
1
Total number of acute healthcare visits for heart failure
Time frame
1 month, 3 months and 6 months2
Total number of unplanned hospitalisations for heart failure
Time frame
1 month, 3 months and 6 months3
Total number of all-cause death
Time frame
1 month, 3 months and 6 months4
Number of days alive out of hospital
Time frame
1 month, 3 months and 6 monthsOther outcomes
1
Healthcare costs
Time frame
1 month, 3 months and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov