Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care (LiLAC-HF)

Linköping University (LiU)

Status

Enrolling

Conditions

Heart Failure

Treatments

Behavioral: ReDS-guided heart failure management program

Study type

Interventional

Funder types

Other

Identifiers

NCT06734065

Dnr 2024-05565-01

Details and patient eligibility

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.

Full 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:

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.
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.

Enrollment

330 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.