Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT06604468
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2024-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Portable Thoracic Impedance Device for Detecting Pulmonary Congestion in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Episodes of decompensated heart failure', 'timeFrame': '90 days', 'description': 'Urgent visit or hospitalisation for worsening of heart failure symptoms requiering diuretic treatment or dialysis'}], 'primaryOutcomes': [{'measure': 'Lung congestion', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'Assessed using lung ultrasound over 12 thoracic zones to calculate the B-line score'}], 'secondaryOutcomes': [{'measure': 'Thoracic water content', 'timeFrame': 'Baseline', 'description': 'Derived using high resolution CT-scan images'}, {'measure': 'Symptom burden', 'timeFrame': 'Baseline, week 4 and week 8', 'description': 'Assessed using the KCCQ-12 questionnaire'}, {'measure': 'NT-pro-BNP', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'Measurement of NT-pro-BNP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bioimpedance', 'heart failure', 'diuretic treatment', 'fluid management'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons with congestive heart failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* 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.\n\nExclusion Criteria:\n\n* Pregnant women at the time of eligibility evaluation.\n* Presence of an implanted electronic device in the thorax, such as a pacemaker or defibrillator.\n* Inability to provide informed consent.\n* Admission to intensive care or the coronary care unit.'}, 'identificationModule': {'nctId': 'NCT06604468', 'acronym': 'DISPLAID1', 'briefTitle': 'A Portable Thoracic Impedance Device for Detecting Pulmonary Congestion in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'A Portable Thoracic Impedance Device for Detecting Pulmonary Congestion in Heart Failure Patients', 'orgStudyIdInfo': {'id': '2025-12000'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with congestive heart failure', 'description': 'Patients with a diagnosis of congestive heart failure', 'interventionNames': ['Diagnostic Test: Thoracic bioimpedance tomography']}], 'interventions': [{'name': 'Thoracic bioimpedance tomography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Data collection using a thoracic bioimpedance tomography device', 'armGroupLabels': ['Patient with congestive heart failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 3H8', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'William Beaubien-Souligny, MD PhD', 'role': 'CONTACT', 'email': 'william.beaubien-souligny.med@ssss.gouv.qc.ca', 'phone': '5143773733'}], 'facility': 'CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'William Beaubien-Souligny, MD PhD', 'role': 'CONTACT', 'email': 'william.beaubien-souligny.med@ssss.gouv.qc.ca', 'phone': '15148908000', 'phoneExt': '12759'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}