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NCT Number: NCT06604468

A Portable Thoracic Impedance Device for Detecting Pulmonary Congestion in Heart Failure Patients

This study investigates a portable thoracic bioimpedance tomography (TBIT) device designed to detect early lung congestion in heart failure patients. The main goal is to evaluate how well the device's measurements match those obtained from lung ultrasound and other imaging techniques. By detecting lung fluid build-up before symptoms worsen, this device could help manage heart failure more effectively outside of hospital settings, potentially improving patient care and reducing hospital admissions. Participants in the study are monitored using this device along with standard imaging methods, and data on heart failure symptoms are collected to understand the device's accuracy and usability.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHUM

Montreal, Quebec, H2X 3H8, Canada

Location status: Recruiting

Location contact

William Beaubien-Souligny, MD PhD

CONTACT

[email protected]

5143773733

About this study

The primary objective is to determine the correlation between TBIT measurements and B-line scores obtained via portable lung ultrasound, with secondary objectives including correlations with thoracic water content from high-resolution CT scans, heart failure symptoms, and NT-proBNP levels adjusted for renal function. Conducted as a prospective, cross-sectional diagnostic study, the research involves heart failure patients recruited during hospital admissions or outpatient visits at heart failure and nephrology clinics. Data collected include TBIT, ultrasound, and CT imaging results, clinical data on heart failure severity, and symptom questionnaires. The study will assess correlations using statistical models such as Spearman's correlation coefficient and mixed-effects models, aiming to validate TBIT as a non-invasive, cost-effective tool for early detection of pulmonary congestion, potentially improving outpatient management and reducing heart failure-related hospitalizations. Ethical considerations include informed consent, confidentiality measures, and ensuring participant safety, with the study procedures being observational and not altering patient treatment based on TBIT results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older.
  • Diagnosed with heart failure, defined by the following criterion: hospitalization or an emergency visit for decompensated heart failure (pulmonary edema) within the last 12 months.

Exclusion criteria

  • Pregnant women at the time of eligibility evaluation.
  • Presence of an implanted electronic device in the thorax, such as a pacemaker or defibrillator.
  • Inability to provide informed consent.
  • Admission to intensive care or the coronary care unit.

Treatment and study plan

Thoracic bioimpedance tomography

Diagnostic Test

Data collection using a thoracic bioimpedance tomography device

Primary outcomes

  1. Lung congestion

    Time frame: Baseline, week 4, week 8

    Assessed using lung ultrasound over 12 thoracic zones to calculate the B-line score

Secondary outcomes

  1. Thoracic water content

    Time frame: Baseline

    Derived using high resolution CT-scan images

  2. Symptom burden

    Time frame: Baseline, week 4 and week 8

    Assessed using the KCCQ-12 questionnaire

  3. NT-pro-BNP

    Time frame: Baseline, week 4, week 8

    Measurement of NT-pro-BNP

Other outcomes

  1. Episodes of decompensated heart failure

    Time frame: 90 days

    Urgent visit or hospitalisation for worsening of heart failure symptoms requiering diuretic treatment or dialysis

Study contacts

Contact information is provided by the study sponsor or research team.

William Beaubien-Souligny, MD PhD

CONTACT

[email protected]

15148908000 ext. 12759

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Acronym: DISPLAID1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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