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

NCT06604468 | Recruiting

• 1 other identifier: 2025-12000
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

bioimpedance; heart failure; diuretic treatment; fluid management

Outcome Measures

Primary Outcomes (1)

• Lung congestion

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

  Baseline, week 4, week 8

Secondary Outcomes (3)

• Thoracic water content

  Baseline

• Symptom burden

  Baseline, week 4 and week 8

• NT-pro-BNP

  Baseline, week 4, week 8

Other Outcomes (1)

• Episodes of decompensated heart failure

  90 days

Study Arms (1)

Patient with congestive heart failure

Patients with a diagnosis of congestive heart failure

Diagnostic Test: Thoracic bioimpedance tomography

Interventions

Thoracic bioimpedance tomography DIAGNOSTIC_TEST

Data collection using a thoracic bioimpedance tomography device

Patient with congestive heart failure

Eligibility Criteria

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

Study Population

Persons with congestive heart failure

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

CHUM

Montreal, Quebec, H2X 3H8, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

William Beaubien-Souligny, MD PhD

CONTACT

15148908000; william.beaubien-souligny.med@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

CA (1)