Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT05775432
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognosis of Heart Transplanted Patients With Heart Failure
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': 'Blood, urine, feces.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2042-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2042-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the incidence of all-cause death', 'timeFrame': 'In-hospital (an average of 1 month), 1, 2, 3, 5, 10, 15 and 20 years after heart transplantation.', 'description': 'Death from any cause in patients after heart transplantation, will be assessed from medical records.'}], 'secondaryOutcomes': [{'measure': 'Use of advanced life support (ALS)', 'timeFrame': 'In-hospital (an average of 1 month)', 'description': 'Duration of ALS after heart transplantation, will be assessed from medical records.'}, {'measure': 'Incidence of postoperative complications', 'timeFrame': 'In-hospital (an average of 1 month)', 'description': 'Postoperative complications after heart transplantation will be assessed from medical records.'}, {'measure': 'ICU admission time', 'timeFrame': 'In-hospital (an average of 1 month)', 'description': 'ICU admission time after heart transplantation, will be assessed from medical records.'}, {'measure': 'Change of cardiac function index', 'timeFrame': 'In-hospital (an average of 1 month).', 'description': 'Cardiac functional index after heart transplantation will be assessed by transthoracic echocardiography.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart transplantation', 'Heart failure', 'Prognosis'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Heart transplantation is the most effective treatment for end-stage heart failure, advanced cardiomyopathy, and complex congenital heart disease with severe heart failure or hypoxia. Several clinical studies have shown significant differences in the prognosis of heart transplantation patients with different etiologies, and post-transplantation complications are an important factor affecting patient survival, and there is still a lack of overall prognostic stratification and extensive clinical studies on risk factors after heart transplantation. Therefore, this study is intended to include patients who underwent heart transplantation for different etiologies of heart failure, collect clinical data and biological samples from patients, and use various techniques to deeply interpret the risk factors affecting the prognosis of heart transplantation patients and construct a prognostic prediction model to provide specific and individualized treatment ideas and theoretical basis for improving the survival rate of patients after heart transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with end-stage heart failure presented to our hospital who are evaluated by clinicians and ethically approved for heart transplantation are enrolled into heart transplantation group. Individuals whose hearts are donated are enrolled into control group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with end-stage heart failure presented to our hospital who are evaluated by clinicians and ethically approved for heart transplantation\n* Individuals whose hearts are donated\n\nExclusion Criteria:\n\n* Patients refuse to sign informed consent form'}, 'identificationModule': {'nctId': 'NCT05775432', 'acronym': 'RE-START', 'briefTitle': 'Prognosis of Heart Transplanted Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Prognosis of Heart Transplanted Patients With Heart Failure (RE-START): a National Multi-center, Retrospective-prospective, Cohort Study', 'orgStudyIdInfo': {'id': 'XJTU1AF2023LSK-391'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart transplantation group', 'description': 'Patients with heart failure of different etiologies undergoing heart transplant.'}, {'label': 'Control group', 'description': 'Individuals whose hearts are donated.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoliang Li', 'role': 'CONTACT', 'email': 'liguoliang_med@163.com'}, {'name': 'Yang Yan', 'role': 'CONTACT', 'email': 'yangyan3@xjtu.edu.cn', 'phone': '+862985323865'}], 'facility': "First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Guoliang Li', 'role': 'CONTACT', 'email': 'liguoliang_med@163.com', 'phone': '+8613759982523'}, {'name': 'Yang Yan', 'role': 'CONTACT', 'email': 'yangyan3@xjtu.edu.cn', 'phone': '+862985323865'}], 'overallOfficials': [{'name': 'Guoliang Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}, {'name': 'Yang Yan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}