Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-29 @ 12:06 PM
Study NCT ID:
NCT05642650
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2022-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Wearable Device for Heart Failure Management
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2022-11-30', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subjects Included the Endpoint of Cardiovascular Mortality', 'timeFrame': 'Up to 6 months', 'description': 'Rate of cardiovascular mortality will be monitored via follow-up.'}, {'measure': 'Subjects Included the Endpoint of all-cause Mortality', 'timeFrame': 'Up to 6 months', 'description': 'Rate of all-cause mortality will be monitored via follow-up.'}], 'primaryOutcomes': [{'measure': 'Rate of Hospital Readmissions for Heart Failure', 'timeFrame': 'Up to 6 months', 'description': 'Total hospitalizations for heart failure will be monitored via follow-up.'}], 'secondaryOutcomes': [{'measure': 'Concordance of the Jugular Vein Pressure with the RHC Measurement', 'timeFrame': 'Up to 6 months', 'description': 'Accuracy of jugular vein pressure measurements by the novel wearable device compared to right heart catheterization.'}, {'measure': 'Change From Baseline N-terminal Pro-brain Natriuretic Peptide(NT-proBNP) or Brain Natriuretic Peptide(BNP)', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline to 6 months in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain Natriuretic Peptide(BNP). NT-proBNP/BNP level will be measured using commercial kits system during the follow-up period. Change from baseline was defined as the value of NT-proBNP/BNP at 6 months minus the baseline value. Baseline value was defined as the mean of all available measurements from the screening visit.'}, {'measure': 'Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance.', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline to 6 months in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions.'}, {'measure': 'Compliance Percentage of Patients', 'timeFrame': 'Up to 6 months', 'description': 'Patient adherence to daily measurement and transmission of sensor readings will be recorded.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Up to 6 months', 'description': 'Quality of life will be measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) answered by the patients directly on a patient application.KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Change in New York Heart Association (NYHA) functional class.', 'timeFrame': 'Up to 6 months', 'description': "NYHA class will be evaluated according to the patients' clinical characteristics during the follow-up.NYHA Functional Classification places patients in one of four categories based on how much they are limited during physical activity; Class I being best and Class IV being the worst functional class. Class I has no limitation to physical activity, Class II has slight limitation to physical activity, Class III has marked limitation of physical activity, and Class IV is unable to carry out any physical activity without severe discomfort."}, {'measure': 'Freedom From a Device/System-related Complication', 'timeFrame': 'Up to 6 months', 'description': 'Device/System-related Complications refer to adverse events such as device failure and allergy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Novel Wearable Device', 'remote monitoring', 'Right heart catheterization'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': "Heart failure (HF) is a major cardiovascular disease with high readmission and mortality rate. A wearable device that could remotely monitor and detect the worsening HF early before the symptoms appear will help reduce HF readmissions effectively. The purpose of the current study is to examine the efficiency of a novel wearable device based on flexible strain sensor comparing to the clinical 'gold standard,' and then transform it into a clinical application.", 'detailedDescription': 'The prospective cohort study aims to examine the efficiency of a novel wearable device based on a flexible strain sensor to improve the outcomes of patients with HF compared to the standard-of-care without wearable device monitoring.\n\nThe primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography,NYHA functional class,left ventricular ejection fraction,natriuretic peptide,additional co-morbidities,and others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of HF ≥ 3 months\n2. Diagnosis of NYHA Class III HF\n3. Subjects with age ≥ 18 years\n4. At least 1 HF hospitalization within 12 months prior to enrollment\n5. Subjects with elevated ambulatory levels of BNP/NT-proBNP\n\nExclusion Criteria:\n\n1. Subjects unable to cooperate to complete the trial.\n2. Subjects with severe arrhythmia.\n3. Subjects with cardiac shock.\n4. Subjects with acute myocardial infarction.\n5. Subjects with local skin infections and injuries in the jugular vein area\n6. Subjects with active uncontrolled infections\n7. Subjects with eGFR \\< 25 mL/min/1.73m2\n8. Pregnant women, or women likely to undergo pregnancy\n9. Subjects with life expectancy less than 6 months'}, 'identificationModule': {'nctId': 'NCT05642650', 'briefTitle': 'Novel Wearable Device for Heart Failure Management', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Clinical Translational Research of Novel Wearable Device Based on Patented Sensing Technology in Non-Invasive Management of Heart Failure', 'orgStudyIdInfo': {'id': '2022-NHLHCRF-YXHZ-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Novel wearable device strategy group', 'description': 'Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps.', 'interventionNames': ['Device: novel wearable device']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients receive a standard of care for heart failure without a wearable device.'}], 'interventions': [{'name': 'novel wearable device', 'type': 'DEVICE', 'description': 'Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps after discharge.', 'armGroupLabels': ['Novel wearable device strategy group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Di Sun, Dr.', 'role': 'CONTACT', 'email': 'sundi0929@163.com', 'phone': '010-84206809'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center', 'investigatorFullName': 'Jingyi Ren', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}