Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT06039969
Status:
UNKNOWN
Last Update Posted:
2023-09-15
First Post:
2023-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate Aerobic Exercise on Myocardial Fibrosis and Intestinal Flora in Dilated Cardiomyopathy Diagnosed First Time.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Cardiac MRI data and patient's feces will be collected.Changes in intestinal flora spectrum will be detected."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'cardiac fitiness', 'timeFrame': 'first admission six months one year', 'description': 'Assessment of caridac fitness based on ardiopulmonary exercise test'}], 'primaryOutcomes': [{'measure': 'myocardial fibrosis', 'timeFrame': 'first admission six months one year', 'description': 'Assessment of myocardial fibrosis based on cardiac MRI examination'}], 'secondaryOutcomes': [{'measure': 'Bacterial spectrum of intestine', 'timeFrame': 'first admission six months one year', 'description': 'Assessment of Bacterial spectrum of intestine based on Patient feces sequencing'}]}, 'conditionsModule': {'keywords': ['Aerobic exercise rehabilitation', 'Myocardial Fibrosis', 'human gut microbiome', 'cardiac magnetic resonance'], 'conditions': ['Cardiac Rehabilitation', 'Myocardial Fibrosis']}, 'descriptionModule': {'briefSummary': 'To invegstive the Changes of Intestinal Flora and the improvements of Cardiac Fibrosis in Patients With Dilated Cardiomyopathy Diagnosed for the First Time by heart Rehabilitation', 'detailedDescription': 'Previous studies have confirmed that Aerobic exercise rehabilitation can reduce the rate of readmission of patients with heart failure and improve their cardiopulmonary endurance and exercise ability. However, whether aerobic exercise rehabilitation can inhibit myocardial fibrosis or delay the progress of fibrosis in patients with heart failure has not been reported. At the same time, some studies have shown that the change of intestinal microbial flora may promote the progress of heart failure, and regular aerobic exercise will also lead to the change of intestinal microbial flora, but whether aerobic exercise rehabilitation can improve intestinal microbial flora in patients with dilated cardiomyopathy has not been reported. In our study, patients who were hospitalized for heart failure for the first time and were finally diagnosed with dilated cardiomyopathy were recruited. Recruited patients will enter the routine cardiac rehabilitation process and make an individualized aerobic exercise plan according to the cardiopulmonary exercise test. Cardiac MRI and intestinal microflora changes will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who were hospitalized for heart failure for the first time and were finally diagnosed with dilated cardiomyopathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1、Patients hospitalized for the first time because of heart failure 2、The patient who was definitely diagnosed as dilated cardiomyopathy for the first time\n\nExclusion Criteria:\n\n* 1、Other types of cardiomyopathy 2、Has been diagnosed as dilated cardiomyopathy. 3、malignant tumor 4、acute infection 5、Cannot perform cardiopulmonary exercise test.'}, 'identificationModule': {'nctId': 'NCT06039969', 'briefTitle': 'Evaluate Aerobic Exercise on Myocardial Fibrosis and Intestinal Flora in Dilated Cardiomyopathy Diagnosed First Time.', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Study on the Changes of Intestinal Flora and Cardiac Fibrosis in Patients With Dilated Cardiomyopathy Diagnosed for the First Time by Sports Rehabilitation', 'orgStudyIdInfo': {'id': '20230911'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac MRI will be performed in patients with heart failure caused by cardiomyopathy.', 'description': 'Cardiac MRI will be performed in patients with heart failure caused by cardiomyopathy. At the same time Collect patient feces.this is a obvertional study ,ther is no intervetion'}], 'interventions': [{'type': 'OTHER', 'description': 'This is an obvertional study and there is no intervention', 'armGroupLabels': ['Cardiac MRI will be performed in patients with heart failure caused by cardiomyopathy.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '223300', 'city': "Huai'an", 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaozhong Yang, MD', 'role': 'CONTACT'}, {'name': 'Hailang Liu, MM', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Huai'An First People'S Hospital", 'geoPoint': {'lat': 33.58861, 'lon': 119.01917}}], 'centralContacts': [{'name': 'Jin Geng, MD', 'role': 'CONTACT', 'email': 'gj885258@163.com', 'phone': '+86-17753124846'}, {'name': 'XiWen Zhang, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'XiWen Zhang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Huai'an First People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate doctor', 'investigatorFullName': 'Jin Geng', 'investigatorAffiliation': 'Nanjing Medical University'}}}}