Screening of Predictive Biomarkers for Cardiorenal Syndrome

NCT07139626 | Recruiting

• 1 other identifier: 2025-K124-01-A
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cardiorenal Syndrome (CRS)

Outcome Measures

Primary Outcomes (2)

• Differences in serum levels of SLPI, serpin E1, CXCL10, CXCL13, and properdin between the screening CHF - only subgroup and screening CHF + CRS subgroup

  At baseline (screening phase).

• Predictive efficacy of the screened biomarkers for CRS development in the validation cohort, evaluated by ROC curves and AUC

  From enrollment to 1- year follow- up (validation phase).

Secondary Outcomes (4)

• Correlations between the screened biomarkers and renal function indicators (creatinine, eGFR)

  At baseline and 1- year follow- up (validation phase).

• Changes in levels of the screened biomarkers between baseline and 1 - year follow - up in the validation CHF - only and validation CRS subgroups

  From enrollment to 1- year follow- up (validation phase).

• Correlation between serum levels of screened biomarkers and serum NT-proBNP levels in the Validation Phase

  At baseline and 1- year follow- up (validation phase).

• Differences in predictive efficacy of the screened biomarkers among CHF subtypes (HFrEF, HFmrEF, HFpEF)

  At 1- year follow- up (validation phase).

Study Arms (3)

Screening Phase：Screening CHF-only Subgroup

30 patients with stable CHF (10 HFrEF, 10 HFmrEF, 10HFpEF) and preserved kidney function (eGFR ≥90mL/min/1.73m' and normal serum creatinine).

Other: This is an observational Study.

Screening Phase：Screening CHF +CRS Subgroup

30 patients with stable CHF (10 HFrEF, 10 HFmrEF, 10HFpEF) and established kidney function (eGFR \<90mL/min/1.73m' and normal serum creatinine).

Other: This is an observational Study.

Validation Phase: Validation Cohort (Baseline Normal Renal Function)

90 patients with stable CHF (30 HFrEF, 30 HFmrEF, 30HFpEF) and preserved kidney function (eGFR ≥ 90mL/min/1.73m' and normal serum creatinine) at enrollment. They will be followed for 1 year and reclassified into: Validation CHF-only Subgroup: Remaining with normal renal function after 1 year. Validation CRS Subgroup: Developed kidney dysfunction(eGFR \<90 mL/min/1.73m' or elevated serum creatinine) after 1 year.

Other: This is an observational Study.

Interventions

This is an observational Study. OTHER

This is an observational study with no study-assigned interventions.Only observational measurements (blood collection for biomarker analysis) will be performed without modifying existing treatments.

Screening Phase：Screening CHF +CRS Subgroup; Screening Phase：Screening CHF-only Subgroup; Validation Phase: Validation Cohort (Baseline Normal Renal Function)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haiyan Pan: lead

Study Sites (1)

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The specific types of samples to be retained are venous serum samples from all study participants, which are the core specimens for biomarker detection and follow-up analysis. Detailed specifications are as follows: 1. Source and Collection Volume: Derived from 5-8 mL of venous blood collected from each participant (using serum separation tubes without anticoagulants). 2. Correspondence to Study Phases: * For the Screening Phase (60 participants in CHF-only and CHF+CRS subgroups): 1 tube of serum sample per participant, collected once at baseline. * For the Validation Phase (90 participants): 2 tubes of serum samples per participant, collected separately at baseline and 1-year follow-up. 3. Key Feature for Retention: All retained serum samples are processed to exclude blood cells and clotting factors (via centrifugation at 3000 rpm for 10 minutes at 4°C within 1 hour of collection), ensuring they are suitable for subsequent detection of target biomarkers (SLPI, Serpin E1, CXCL10, CXC

MeSH Terms

Conditions

Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chief Physician, Department of Cardiology

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)