Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
Study NCT ID:
NCT04269057
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2020-01-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in HFpEF Patients Treated With ARNI
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'monocytes and serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks', 'timeFrame': '12 weeks', 'description': 'Measuring the level of TNFα, IL-1β, NLRP3 inflammasome, and so on from blood samples at 12 weeks, seperately by PCR and ELISA'}], 'secondaryOutcomes': [{'measure': 'The change from baseline in echocardiographic measures and so on', 'timeFrame': '12 months', 'description': 'Observed the change of ejection fraction, left atrial volume index and so on measured by echocardiogram.'}, {'measure': 'The change from baseline in quality of life', 'timeFrame': '12 months', 'description': 'Measured by Kansas City Cardiomyopathy Questionnaire. The score ranges from 0 to 100. The higher score means the better health-related quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NLRP3 protein', 'human'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Underlying inflammation has been increasingly recognized in heart failure with a preserved ejection fraction(HFpEF). But there is no study reported the relationship between NLRP3 inflammasome and HFpEF. In this study, investigators propose a scientific hypothesis that the expression of NLRP3 inflammasome is elevated in patients with HFpEF, and the level of TNFα, IL-1β and NLRP3 inflammasome is lower in patients treated with sacubitril/valsartan.', 'detailedDescription': 'The study will integrate data from two trials involving a total of 90 participants with heart failure. Depending on the using of ARNI, participants in HFpEF group will be divided into two groups. The diagnostic criteria for HFpEF is: (1) left ventricular ejection fraction ≥50%； (2）with the symptoms and/or signs of heart failure; (3) BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL; (4) at least one additional criterion: a.relevant structural heart disease(LVH and/or LAE); b.diastolic dysfunction. The primary outcome are the change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks. The key secondary outcomes include changes in echocardiographic measures, quality of life, etc. And then compare the rate of above indicators of two trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'heart failure patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* left ventricular ejection fraction ≥50%；\n* with the symptoms and/or signs of heart failure；\n* BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；\n* at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction.\n\nExclusion Criteria:\n\n* LVEF less than 45% at any time;\n* severe infection;\n* ACS;\n* pregnancy;\n* eGFR \\<30 mL/min/1.73 m2, etc.'}, 'identificationModule': {'nctId': 'NCT04269057', 'briefTitle': 'Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in HFpEF Patients Treated With ARNI', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': 'Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in Patients With Heart Failure With Preserved Ejection Fraction Treated With ARNI', 'orgStudyIdInfo': {'id': '2019-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HFpEF', 'description': 'heart failure patients with preserved ejection fraction who using ARNI'}, {'label': 'HFrEF', 'description': 'heart failure patients with reduced ejection fraction who using ARNI'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongying Zhang, doctor', 'role': 'CONTACT', 'email': 'zdy.chris@qq.com', 'phone': '+8613608398395'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Dongying Zhang, doctor', 'role': 'CONTACT', 'email': 'zdy.chris@qq.com', 'phone': '+8613608398395'}], 'overallOfficials': [{'name': 'Dongying Zhang, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dongying Zhang', 'investigatorAffiliation': 'Chongqing Medical University'}}}}