Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care

NCT06734065 | Recruiting

• 1 other identifier: Dnr 2024-05565-01
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart failure; Primary care; Nursing; Monitoring; Self-care; Community

Outcome Measures

Primary Outcomes (1)

• Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death

  3 months

Secondary Outcomes (9)

• Total number of acute healthcare visits for heart failure

  1 month, 3 months and 6 months

• Total number of unplanned hospitalisations for heart failure

  1 month, 3 months and 6 months

• Total number of all-cause death

  1 month, 3 months and 6 months

• Number of days alive out of hospital

  1 month, 3 months and 6 months

• Changes in NT-proBNP/BNP levels

  Baseline, 3 months and 6 months

Other Outcomes (1)

• Healthcare costs

  1 month, 3 months and 6 months

Study Arms (2)

Usual care group

NO INTERVENTION

Patients in the usual care group will receive usual care.

ReDS-guided heart failure management group

EXPERIMENTAL

Behavioral: ReDS-guided heart failure management program

Interventions

ReDS-guided heart failure management program BEHAVIORAL

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 pulmonary fluid levels assessed by ReDS.

ReDS-guided heart failure management group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Primary care center Centrum Flen

Flen, Sweden

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Naoko Perkiö Kato, PhD

CONTACT

+46 (0)11-36 31 17; naoko.perkio.kato@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 16, 2024
• Study Start: April 16, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)