Recruiting

TBIT

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06604468

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thoracic bioimpedance tomography

Study Details

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

Study ID

NCT06604468

Start date

Sep 1, 2025

Status verified date

Sep, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Patient with congestive heart failure

Patients with a diagnosis of congestive heart failure

Interventions

Thoracic bioimpedance tomography

Data collection using a thoracic bioimpedance tomography device

Primary outcome measure

  • Lung congestion [ Time Frame: Baseline, week 4, week 8 ]

Central Contacts and Locations

Central contacts

William Beaubien-Souligny, MD PhD

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

Locations

CHUM

Recruiting

Montreal, Quebec, Canada, H2X 3H8

Contacts

William Beaubien-Souligny, MD PhD

5143773733william.beaubien-souligny.med@ssss.gouv.qc.ca

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Oct 6, 2025

Last verified

Sep, 2025

Keywords

  • bioimpedance
  • heart failure
  • diuretic treatment
  • fluid management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-10-06.