Screening of Predictive Biomarkers for Cardiorenal Syndrome
Recruiting · NCT07139626 · Observational (researchers observe without assigning treatment) · Lead sponsor: Haiyan Pan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study aims to explore the predictive value of specific biomarkers for cardiorenal syndrome (CRS) in patients with chronic heart failure (CHF). Building 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. Adults 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. The participants will: Provide blood samples for the detection of biomarkers and liver and kidney function indicators. Receive one year of standardized heart failure treatment. Undergo regular follow-up visits.
Who can take part
Inclusion criteria
- Adults aged 18 to 75 years.
- Diagnosed with stable chronic heart failure (HF) according to the 2024 Chinese Heart Failure Diagnosis and Treatment Guideline.
- HF subtypes include:
- HFrEF (LVEF ≤40%), HFmrEF (LVEF 41 - 49%), HFpEF (LVEF ≥50%).
- Willing to provide blood samples for biomarker analysis.
- Able to comply with follow - up visits and study procedures for 12 months.
- 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.
Exclusion criteria
- History of long-term dialysis or kidney surgery.
- Acute kidney injury (AKI) within the past 3 months.
- Use of nephrotoxic drugs within the past 3 months.
- Diagnosis of autoimmune diseases (e.g., lupus, rheumatoid arthritis).
- Active malignancy or history of cancer treatment within the past 5 years.
- Acute infectious diseases at the time of enrollment.
- Severe liver dysfunction (e.g., cirrhosis, ALT/AST \>3× upper limit of normal).
- Pregnancy or lactation.
- Inability or unwillingness to provide informed consent.
- Participation in another interventional clinical trial within the past 30 days.
Where it is running
2 locations listed.
- The Affiliated Hospital of Nantong University - Nantong, Jiangsu, China
- The Affiliated Hospital of Nantong University - Nantong, Jiangsu, China