Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care
Recruiting · NCT06734065 · Interventional (participants receive a specific treatment) · Lead sponsor: Linkoeping University
View the official record on ClinicalTrials.gov →Interventions studied
ReDS-guided heart failure management program
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Primary care center Centrum Flen - Flen, Sweden