Screening of Predictive Biomarkers for Cardiorenal Syndrome
ConditionCardiorenal Syndrome (CRS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHaiyan Pan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 75 years.
Diagnosed with stable chronic heart failure (HF) according to the 2024 Chinese Heart Failure Diagnosis and Treatment Guideline.
Willing to provide blood samples for biomarker analysis.
Able to comply with follow - up visits and study procedures for 12 months.
Disqualifiers
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).
Trial population
Participants will be recruited from chronic heart failure (CHF) patients attending the cardiology outpatient clinics or admitted to the cardiology wards of a tertiary care hospital in China. The study focuses on adults with stable CHF(HFrEF, HFmrEF, HFpEF). The hospital is a regional referral center with a high volume of HF cases, ensuring a diverse and representative sample. Eligible patients will be enrolled based on clinical diagnosis and willingness to participate in biomarker analysis and follow-up assessments.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
This is an observational Study.
Other interventionThis is an observational study with no study-assigned interventions.Only observational measurements (blood collection for biomarker analysis) will be performed without modifying existing treatments.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Screening Phase：Screening CHF-only Subgroup1 intervention
Group B: Screening Phase：Screening CHF +CRS Subgroup1 intervention
Group C: Validation Phase: Validation Cohort (Baseline Normal Renal Function)1 intervention
Trial outcomes
Primary outcomes
1
Differences in serum levels of SLPI, serpin E1, CXCL10, CXCL13, and properdin between the screening CHF - only subgroup and screening CHF + CRS subgroup
Time frame
At baseline (screening phase).2
Predictive efficacy of the screened biomarkers for CRS development in the validation cohort, evaluated by ROC curves and AUC
Time frame
From enrollment to 1- year follow- up (validation phase).Secondary outcomes
1
Correlations between the screened biomarkers and renal function indicators (creatinine, eGFR)
Time frame
At baseline and 1- year follow- up (validation phase).2
Changes in levels of the screened biomarkers between baseline and 1 - year follow - up in the validation CHF - only and validation CRS subgroups
Time frame
From enrollment to 1- year follow- up (validation phase).3
Correlation between serum levels of screened biomarkers and serum NT-proBNP levels in the Validation Phase
Evaluate the correlation between the serum concentration of each screened biomarker (SLPI, Serpin E1, CXCL10, CXCL13, Properdin) and the serum concentration of N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) in participants of the Validation Phase. * Measurement Details: * Screened biomarkers: Serum concentration (unit: pg/mL), measured by enzyme-linked immunosorbent assay (ELISA) kits (commercially available, validated for sensitivity ≥ 0.1 pg/mL and inter-assay CV \< 10%). * NT-proBNP: Serum concentration (unit: pg/mL), measured by chemiluminescence immunoassay (CLIA) using an automated clinical chemistry analyzer (e.g., Roche Cobas e601). * Correlation Analysis Method: Pearson correlation (for normally distributed data) or Spearman correlation (for non-normally distributed data) will be used to calculate the correlation coefficient (r) and statistical significance (P-value).
Time frame
At baseline and 1- year follow- up (validation phase).4
Differences in predictive efficacy of the screened biomarkers among CHF subtypes (HFrEF, HFmrEF, HFpEF)
Time frame
At 1- year follow- up (validation phase).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Haiyan Pan
Lead sponsor
Affiliated Hospital of Nantong University
Sponsor institution
Source ClinicalTrials.gov