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

Not yet recruiting

• Conditions: Heart Failure
• Interventions: Diagnostic Test: Thoracic bioimpedance tomography

• Registration Number: NCT06604468
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-18
• Study First Posted: 2024-09-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Study Start: 2025-06-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with congestive heart failure	Thoracic bioimpedance tomography	Patients with a diagnosis of congestive heart failure

Primary Outcome Measures

Name	Time	Method
Lung congestion	Baseline, week 4, week 8	Assessed using lung ultrasound over 12 thoracic zones to calculate the B-line score

Secondary Outcome Measures

Name	Time	Method
Thoracic water content	Baseline	Derived using high resolution CT-scan images
Symptom burden	Baseline, week 4 and week 8	Assessed using the KCCQ-12 questionnaire
NT-pro-BNP	Baseline, week 4, week 8	Measurement of NT-pro-BNP