Assessing cardiovascular and kidney health using metabolomics in patients with heart disease

Cardiovascular-Renal Adverse oUtcome rIsk aSsessment systEm for Coronary Heart Disease Complicated With Chronic Kidney Disease Based on Targeted Lipid METabolomics

This study is testing if certain fat-related substances in the blood can help predict health outcomes for adults with both heart disease and kidney problems.

Quick facts

• Study type: Observational
• Enrollment: 470 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: China-Japan Friendship Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06383208 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the relationship between lipid metabolites and the prognosis of patients suffering from both coronary heart disease (CHD) and chronic kidney disease (CKD). By analyzing specific lipid metabolites that are elevated in patients with reduced kidney function, the study seeks to identify potential biomarkers that could indicate adverse outcomes. The research focuses on patients aged 18-80 who have been diagnosed with CHD and have clarified renal function status. The findings could provide insights into the cardiovascular-kidney-metabolic syndrome and improve risk assessment for these patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 diagnosed with coronary heart disease and chronic kidney disease.

Not a fit: Patients with severe psychiatric illnesses, end-stage renal disease, or those who have undergone kidney transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prognostic assessments and targeted interventions for patients with both coronary heart disease and chronic kidney disease.

How similar studies have performed: While the approach of using lipid metabolomics is emerging, similar studies have shown promise in identifying biomarkers for cardiovascular and renal diseases.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80 years old;
2. Diagnosed with CHD during hospitalization through coronary angiography, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation acute coronary syndrome (NST-ACS), stable angina pectoris;
3. Patients with clarified renal function status.;

CKD is defined as meeting one of the following criteria, with a duration of more than 3 months: eGFR \< 60 ml/min/1.73 m² or eGFR ≥ 60 ml/min/1.73 m² and urinary albumin-to-creatinine ratio (uACR) ≥ 30 mg/g;

Exclusion Criteria:

1. Pregnancy or lactation;
2. Severe valve disease or severe mechanical complications requiring surgical intervention;
3. Severe psychiatric illness or other reasons that impede follow-up compliance;
4. Severe hematologic disorders or end-stage malignant tumors;
5. Having undergone kidney transplantation or long-term maintenance dialysis;
6. Severe liver disease (Child-Pugh class C);
7. Received acute renal failure dialysis treatment within 12 weeks prior to screening for enrollment;
8. Severe chronic lung disease requiring long-term mechanical ventilation support or awaiting lung transplantation;
9. Life expectancy less than 1 year.

Where this trial is running

Beijing, Beijing Municipality

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Zheng Jingang, MD — China-Japan Friendship Hospital
• Study coordinator: Chen Qiang

Conditions: Chronic Kidney Diseases, Coronary Heart Disease, Lipid Metabolism Disorders, Cardiovascular-Renal adverse prognosis, Metabolomics