Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-28 @ 4:51 AM
Study NCT ID:
NCT01377350
Status:
UNKNOWN
Last Update Posted:
2011-06-21
First Post:
2011-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-20', 'studyFirstSubmitDate': '2011-05-18', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'earliest non-invasive signs for lung congestion and deterioration in the heart failure', 'timeFrame': '18 months', 'description': 'Exploring the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart failure', 'monitoring'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.', 'detailedDescription': "Pulmonary veins congestion and fine changes in alveolar transudative effusion accumulation affect lung mechanics (compliance) and the respiratory effort. Moreover, the associated state of oxygen de-saturation is compensated by an increase in the respiratory effort. These changes in the respiratory effort are reflected in chest wall dynamics and may provide the earliest non-invasive sign for lung congestion and deterioration in the heart failure.\n\nThe research system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation. The signals are acquired by a miniaturized device that amplifies and samples the signals, stores and analyzes the data and displays the trends on the screen."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute decompensated HF\n* Decompensated chronic HF in patients with NYHA class III-IV symptoms\n* Age over 20 years\n* Ejection fraction reduced below 35% OR doppler evidence of impaired left ventricular diastolic filling\n\nExclusion Criteria:\n\n* Inability or unwillingness to follow the study protocol'}, 'identificationModule': {'nctId': 'NCT01377350', 'briefTitle': 'Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System', 'orgStudyIdInfo': {'id': '0550-10ctil'}, 'secondaryIdInfos': [{'id': 'ministry of health Israel', 'type': 'OTHER', 'domain': 'ministry of health Israel'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"Pneumedicare"s monitoring system', 'description': 'Single arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients', 'interventionNames': ['Device: "Pneumedicare"s monitoring system.', 'Device: "Pneumedicare"s monitoring system']}], 'interventions': [{'name': '"Pneumedicare"s monitoring system.', 'type': 'DEVICE', 'otherNames': ['"Pneumedicare"s monitoring system for heart failure patients'], 'description': "50 patients hospitalized due to the decompensated HF are considered for entry. 3 patches will be attached to the patients' thorax that include motion sensors. The system will be attached to the patients at the start of treatment. Patient's signals will be recorded during the entire treatment in the hospital, to the point that there is an improvement in their health condition.", 'armGroupLabels': ['"Pneumedicare"s monitoring system']}, {'name': '"Pneumedicare"s monitoring system', 'type': 'DEVICE', 'otherNames': ['"Pneumedicare"s monitoring system for heart failure patients'], 'description': "Non invasive clinical follow-up of patients with HF deterioration and improvement, by a device-based algorithm. The system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation.", 'armGroupLabels': ['"Pneumedicare"s monitoring system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'contacts': [{'name': 'Shmuel Rispler, MD PhD', 'role': 'CONTACT', 'email': 's_rispler@rambam.health.gov.il', 'phone': '972-4-8542180'}, {'name': 'Amir Landesberg, MD PhD', 'role': 'CONTACT', 'email': 'Amir@bm.technion.ac.il', 'phone': '972-505482249'}, {'name': 'Shmuel Rispler, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Shmuel rispler, MD PhD', 'role': 'CONTACT', 'email': 's_rispler@rambam.health.gov.il', 'phone': '972-4-8542180'}, {'name': 'Amir Landesberg, MD PhD', 'role': 'CONTACT', 'email': 'Amir@bm.technion.ac.il', 'phone': '972-505482249'}], 'overallOfficials': [{'name': 'Shmuel Rispler, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Medical Center Haifa Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Shmuel Rispler', 'oldOrganization': 'Rambam Health Care Campus, P.O.B. 9602, Haifa 31096, Israel'}}}}