[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603677":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":10,"locations":27,"responsibleParty":47,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":10,"overallStatus":30,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Affiliated Hospital of Nantong University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Screening Phase：Screening CHF-only Subgroup",null,"30 patients with stable CHF (10 HFrEF, 10 HFmrEF, 10HFpEF) and preserved kidney function (eGFR ≥90mL\u002Fmin\u002F1.73m' and normal serum creatinine).",[13],"Other: This is an observational Study.",{"label":15,"type":10,"description":16,"interventionNames":17},"Screening Phase：Screening CHF +CRS Subgroup","30 patients with stable CHF (10 HFrEF, 10 HFmrEF, 10HFpEF) and established kidney function (eGFR \\\u003C90mL\u002Fmin\u002F1.73m' and normal serum creatinine).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Validation Phase: Validation Cohort (Baseline Normal Renal Function)","90 patients with stable CHF (30 HFrEF, 30 HFmrEF, 30HFpEF) and preserved kidney function (eGFR ≥ 90mL\u002Fmin\u002F1.73m' and normal serum creatinine) at enrollment. They will be followed for 1 year and reclassified into: Validation CHF-only Subgroup: Remaining with normal renal function after 1 year.\n\nValidation CRS Subgroup: Developed kidney dysfunction(eGFR \\\u003C90 mL\u002Fmin\u002F1.73m' or elevated serum creatinine) after 1 year.",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"This is an observational Study.","This is an observational study with no study-assigned interventions.Only observational measurements (blood collection for biomarker analysis) will be performed without modifying existing treatments.",[15,9,19],[28],{"facility":29,"status":30,"city":31,"state":32,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The Affiliated Hospital of Nantong University","RECRUITING","Nantong","Jiangsu","China","CN",{"type":36,"coordinates":37},"Point",[38,39],120.87472,32.03028,{"lat":39,"lon":38},[42],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"Pan","CONTACT","+86 13906291842","dr.phy@qq.com",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Haiyan Pan","Professor and Chief Physician, Department of Cardiology","100603677","screening-of-predictive-biomarkers-for-cardiorenal-syndrome-100603677",false,"NCT07139626","Screening of Predictive Biomarkers for Cardiorenal Syndrome","Screening and Validation of Serum Biomarkers (SLPI, Serpin E1, CXCL10, CXCL13, Properdin) for Predicting Cardiorenal Syndrome in Patients With Chronic Heart Failure: A Prospective Cohort Study","Inclusion Criteria:\n\n* Adults aged 18 to 75 years.\n* Diagnosed with stable chronic heart failure (HF) according to the 2024 Chinese Heart Failure Diagnosis and Treatment Guideline.\n* HF subtypes include:\n\nHFrEF (LVEF ≤40%), HFmrEF (LVEF 41 - 49%), HFpEF (LVEF ≥50%).\n\n* Willing to provide blood samples for biomarker analysis.\n* Able to comply with follow - up visits and study procedures for 12 months.\n* Note: For the screening phase, 10 patients will be included for each subtype; for the validation phase, 30 patients will be included for each subtype.\n\nExclusion Criteria:\n\n* History of long-term dialysis or kidney surgery.\n* Acute kidney injury (AKI) within the past 3 months.\n* Use of nephrotoxic drugs within the past 3 months.\n* Diagnosis of autoimmune diseases (e.g., lupus, rheumatoid arthritis).\n* Active malignancy or history of cancer treatment within the past 5 years.\n* Acute infectious diseases at the time of enrollment.\n* Severe liver dysfunction (e.g., cirrhosis, ALT\u002FAST \\>3× upper limit of normal).\n* Pregnancy or lactation.\n* Inability or unwillingness to provide informed consent.\n* Participation in another interventional clinical trial within the past 30 days.","ALL","18 Years","75 Years",{"count":62,"type":63},150,"ESTIMATED","OBSERVATIONAL","This study aims to explore the predictive value of specific biomarkers for cardiorenal syndrome (CRS) in patients with chronic heart failure (CHF).\n\nBuilding on previous research using Luminex technology, which identified that serum levels of SLPI, serpin E1, CXCL10, and CXCL13 were significantly higher, while properdin levels were lower in patients with post-cardiac surgery acute kidney injury (AKI) compared to those without renal impairment, this study will further investigate these biomarkers in the context of CRS.\n\nAdults aged 18-75 with stable CHF (including HFrEF, HFmrEF, and HFpEF subtypes) will be conducted in two phases:1. Screening phase: Compare serum levels of the above biomarkers between 30 CHF patients without kidney dysfunction and 30 CHF patients with CRS to identify biomarkers with significant differences. 2. Validation phase: Follow 90 CHF patients with normal kidney function for 1 year, and divide them into CHF-only and CRS groups based on renal function (creatinine and eGFR) after 1 year. The study will verify the predictive value of the screened biomarkers by comparing their levels before and after follow-up, analyzing correlations with NT-proBNP, creatinine, and eGFR, and using receiver operating characteristic (ROC) curves and area under the curve (AUC) to evaluate their predictive efficacy for CRS. The optimal predictive biomarker for this syndrome will be determined.\n\nThe participants will:\n\nProvide blood samples for the detection of biomarkers and liver and kidney function indicators.\n\nReceive one year of standardized heart failure treatment. Undergo regular follow-up visits.",[67],"Cardiorenal Syndrome (CRS)","2026-02-24",{"date":70,"type":71},"2026-02-27","ACTUAL",{"date":73,"type":71},"2025-09-15",{"date":75,"type":63},"2027-12-31",{"name":49,"class":6},1]