Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06734065

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

Led by Linkoeping University · Updated on 2025-04-27

330

Participants Needed

1

Research Sites

293 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older with no upper age limit
  • Diagnosed with heart failure regardless of left ventricular ejection fraction
  • New York Heart Association (NYHA) Class III or IV regardless of prior hospitalization for heart failure, or NYHA Class II with at least one heart failure hospitalization in the past 12 months
  • Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) within 12 months: (a) 450 pg/ml or higher for patients under 50 years (b) 900 pg/ml or higher for patients aged 50 to 75 years (c) 1800 pg/ml or higher for patients over 75 years
Not Eligible

You will not qualify if you...

  • NYHA Class I heart failure
  • Life expectancy less than 6 months
  • Body mass index less than 22 or greater than 39, or height less than 155 cm or greater than 195 cm, preventing use of the ReDS device
  • Implantation of a left ventricular assist device or cardiac transplantation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Primary care center Centrum Flen

Flen, Sweden

Actively Recruiting

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Research Team

N

Naoko Perkiö Kato, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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