Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-01-01 @ 11:29 PM
Study NCT ID:
NCT05397392
Status:
RECRUITING
Last Update Posted:
2022-06-02
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2022-05-26', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalization due to worsening of renal or cardiac function', 'timeFrame': '1 year', 'description': 'eGFR continuously decreased by more than 25% within one year; NYHA cardiac function class III or above requires intravenous pharmacological agents; deterioration of cardiac or kidney function requiring dialysis'}, {'measure': 'All-cause deaths', 'timeFrame': '1 year', 'description': 'Deaths due to disease progression'}], 'secondaryOutcomes': [{'measure': 'End-stage renal disease requires maintenance dialysis', 'timeFrame': '1 year', 'description': 'eGFR\\<15ml/min, combined with one of the following conditions: 1. Uremia symptoms that cannot be alleviated by limiting protein intake; 2. Hyperkalemia that is difficult to correct; 3. Progressive metabolic acidosis that is difficult to control; 4. Uncontrollable water and sodium retention, combined with congestive heart failure or acute pulmonary edema; 5. Uremic pericarditis; 6. Uremic encephalopathy and progressive neuropathy.'}, {'measure': 'Acute kidney injury', 'timeFrame': '1 year', 'description': 'increase in Scr ≥0.3 mg/dL (26.5 μmol/L) within 48 h, or increase in Scr ≥1.5 times baseline in 7 days, or urine volume \\<0.5 mL/kg/h for 6 h.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Kidney Diseases', 'Kidney Injury', 'Heart Valve Diseases', 'Dialysis; Complications', 'Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'To estimate the characteristics, pathogenesis, risk factors and intervention measures for different stages of heart and kidney diseases, and to optimize the curative effects of different treatment schemes', 'detailedDescription': 'Cardiorenal syndrome is a clinical syndrome caused by acute or chronic injury of one of the heart and kidney resulting to acute or chronic dysfunction of the other organ. In recent years, the morbidity of cardiorenal syndrome has increased rapidly in China. Its condition is complex and difficult to treat. Due to the lack of studies specifically targeting the cardiorenal syndrome population, there is no systematic in-depth understanding of the pathogenesis and risk factors of this kind of disease. In clinic, the course of various types of cardiorenal syndrome is complex and difficult to be summarized into a specific type. Therefore, we intend to conduct a clinical systematic observation and research on such patients so as to optimize a more reasonable treatment scheme.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from a tertiary hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients meet the diagnosis of various types of cardiorenal syndrome according to the classification standards of various types formulated by KDIGO and ADQI expert consensus. Different syndromes were identified and classified into five subtypes. Acute CRS (type 1): acute worsening of heart function (AHF-ACS) leading to kidney injury and/or dysfunction. Chronic cardio-renal syndrome (type 2): chronic abnormalities in heart function (CHF-CHD) leading to kidney injury and/or dysfunction. Acute reno-cardiac syndrome (type 3): acute worsening of kidney function (AKI) leading to heart injury and/or dysfunction. Chronic reno-cardiac syndrome (type 4): chronic kidney disease leading to heart injury, disease, and/or dysfunction. Secondary CRS (type 5): systemic conditions leading to simultaneous injury and/or dysfunction of heart and kidney.\n\nExclusion Criteria:\n\nPregnant or breastfeeding women; Female patients with recent birth plans; Patients who cannot follow up on medications.'}, 'identificationModule': {'nctId': 'NCT05397392', 'acronym': 'ODT-CRS', 'briefTitle': 'Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome', 'orgStudyIdInfo': {'id': 'KY20220425-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute kidney injury', 'description': 'Acute kidney injury caused by heart disease or cardiac dysfunction due to acute renal damage', 'interventionNames': ['Other: guideline recommended routine treatment']}, {'label': 'chornic kidney disease', 'description': 'Chornic kidney injury caused by heart disease or cardiac dysfunction due to chronic kidney disease', 'interventionNames': ['Other: guideline recommended routine treatment']}], 'interventions': [{'name': 'guideline recommended routine treatment', 'type': 'OTHER', 'armGroupLabels': ['acute kidney injury', 'chornic kidney disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yue Zhou, master of medicine', 'role': 'CONTACT', 'email': '56005460@qq.com', 'phone': '+8615380998793'}, {'name': 'Xiao-xia Chen, master of medicine', 'role': 'CONTACT', 'email': 'zygyx2022@163.com', 'phone': '+8615380998950'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}