CHUM
Montreal, Quebec, H2X 3H8, Canada
Location status: Recruiting
NCT Number: NCT06604468
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Montreal, Quebec, H2X 3H8, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Data collection using a thoracic bioimpedance tomography device
Time frame: Baseline, week 4, week 8
Assessed using lung ultrasound over 12 thoracic zones to calculate the B-line score
Time frame: Baseline
Derived using high resolution CT-scan images
Time frame: Baseline, week 4 and week 8
Assessed using the KCCQ-12 questionnaire
Time frame: Baseline, week 4, week 8
Measurement of NT-pro-BNP
Time frame: 90 days
Urgent visit or hospitalisation for worsening of heart failure symptoms requiering diuretic treatment or dialysis
Contact information is provided by the study sponsor or research team.
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Acronym: DISPLAID1
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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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