Non-invasive lung fluid monitoring for managing heart failure in primary care
Official title: Effect of Non-Invasive Lung Fluid Monitoring Using ReDS Technology for Heart Failure Management in Primary Care Settings: A Randomized Controlled Trial
Run by Linkoeping University · NCT06734065 · Data updated 2026-11-12
This study is testing a new way for nurses to use a special device to check lung fluid levels in heart failure patients to see if it helps them avoid hospital visits and live healthier lives.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 330 (estimated) |
| Sponsor | Linkoeping University Government |
| Locations | 1 site (Flen) |
| Status | Recruiting |
| Started | April 16, 2025 |
| Main results expected | July 2030 |
| Study ends | December 2030 |
| Registry record updated | April 27, 2025 |
| Trial ID | NCT06734065 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older diagnosed with heart failure, particularly those with NYHA Class II, III, or IV symptoms.
✕Probably not a fit
Patients with NYHA Class I heart failure or those with a life expectancy of less than 6 months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of a ReDS-guided heart failure management program in primary care settings. The program utilizes remote dielectric sensing technology to non-invasively assess lung congestion and is led by nurses who implement algorithms for follow-up, diuretic adjustments, and symptom monitoring. The study aims to reduce urgent healthcare visits, unplanned hospitalizations, and all-cause mortality in heart failure patients while also assessing the implementation processes and barriers. Participants will be monitored over a 6-month period to gather data on health-related quality of life and healthcare costs.
Why it matters
Potential benefit: If successful, this program could significantly improve heart failure management and reduce hospitalizations for patients.
How similar studies have gone: Other studies utilizing remote monitoring technologies for heart failure management have shown promising results, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Primary care center Centrum Flen
Flen, Sweden Recruiting
Study contacts
- Study coordinator: Naoko Perkiö Kato, PhD
- Email: naoko.perkio.kato@liu.se
- Phone: +46 (0)11-36 31 17
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.