NCT07139626Recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 18 Aug 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Haiyan Pan
- Diseases
- Heart failure
- NCT number
- NCT07139626
What you commit to
- Study type: Observational
- Planned participants: 150
- From 15 Sept 2025 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of nephrotoxic drugs within the past 3 months.
Other illness
- History of long-term dialysis or kidney surgery.
- 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.
Lab values
- Severe liver dysfunction (e.g., cirrhosis, ALT/AST \>3× upper limit of normal).
Other
- Acute kidney injury (AKI) within the past 3 months.
- Pregnancy or lactation.
- Inability or unwillingness to provide informed consent.
- Participation in another interventional clinical trial within the past 30 days.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.