Actively Recruiting
Screening of Predictive Biomarkers for Cardiorenal Syndrome
Led by Haiyan Pan · Updated on 2026-02-27
150
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Screening of Predictive Biomarkers for Cardiorenal Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with stable chronic heart failure according to the 2024 Chinese Heart Failure Diagnosis and Treatment Guideline
- Heart failure subtypes include HFrEF (LVEF 60;40%), HFmrEF (LVEF 41 - 49%), and HFpEF (LVEF 60;50%)
- Willing to provide blood samples for biomarker analysis
- Able to comply with follow-up visits and study procedures for 12 months
- For the screening phase, include 10 patients per heart failure subtype; for the validation phase, include 30 patients per subtype
You will not qualify if you...
- History of long-term dialysis or kidney surgery
- Acute kidney injury within the past 3 months
- Use of nephrotoxic drugs within the past 3 months
- Diagnosis of autoimmune diseases such as lupus or rheumatoid arthritis
- Active cancer or cancer treatment in the past 5 years
- Acute infectious diseases at enrollment
- Severe liver dysfunction, including cirrhosis or ALT/AST over three times the upper limit of normal
- Pregnancy or lactation
- Unable or unwilling to provide informed consent
- Participation in another interventional clinical trial within the past 30 days
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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