Blood markers that may predict cardiorenal syndrome in people with chronic heart failure

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

This project will test whether five blood proteins (SLPI, Serpin E1, CXCL10, CXCL13, and Properdin) can predict cardiorenal syndrome in adults with stable chronic heart failure.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Affiliated Hospital of Nantong University (Academic / other)
• Locations: 1 site (Nantong, Jiangsu)
• Trial ID: NCT07139626 on ClinicalTrials.gov

What this trial studies

This prospective observational cohort will screen and validate five serum biomarkers (SLPI, Serpin E1, CXCL10, CXCL13, and Properdin) as predictors of cardiorenal syndrome (CRS) in adults with stable chronic heart failure (CHF). The screening phase compares biomarker levels between 30 CHF patients without kidney dysfunction and 30 CHF patients with established CRS using Luminex-based assays, and biomarkers with significant differences will be prioritized. In the validation phase, 90 CHF patients with normal kidney function will be followed for 12 months to determine which biomarkers predict subsequent development of CRS. The work builds on prior Luminex-based findings in post-cardiac surgery acute kidney injury that linked inflammatory, complement, and endothelial pathways to kidney injury and cardiorenal interactions.

Who should consider this trial

Good fit: Adults aged 18–75 with stable chronic heart failure (HFrEF, HFmrEF, or HFpEF) who can provide blood samples and complete 12 months of follow-up are eligible.

Not a fit: Patients with recent AKI, long-term dialysis or kidney surgery, active infections, autoimmune disease, recent cancer treatment, severe liver dysfunction, or recent use of nephrotoxic drugs are excluded and unlikely to benefit from the results.

Why it matters

Potential benefit: If successful, these biomarkers could enable earlier identification of CHF patients at high risk for CRS, allowing preventive measures and closer monitoring.

How similar studies have performed: Previous Luminex-based analyses found these biomarkers were altered in patients with post-cardiac surgery acute kidney injury, providing supportive preliminary evidence, though CRS-specific validation remains limited.

Eligibility criteria

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 this trial is running

Nantong, Jiangsu

• The Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)

Conditions Cardiorenal Syndrome