Association of Cardiac Biomarkers of Heart Failure and Iron Status in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Measures of iron status
研究概览
简要总结
Background:
Peripheral arterial disease (PAD) a condition characterized by atherosclerotic occlusive disease of the lower extremities is commonly observed in patients with chronic kidney disease (CKD) patients, particularly those on dialysis. We conducted detailed biomarkers such as thrombospondin and related inflammatory biomarkers for the risk of developing and presence of PAD. Thrombospondin-4 (TSP-4) is an extracellular matrix protein of the vessel wall. Despite bench evidence, its significance in the clinical setting of chronic kidney disease (CKD) is missing
Methods:
This is a cross-sectional, single-center study. A cohort of 450 patients aged 20 or over, who have been on HD for at least 3 months prior to enrollment (Dec 1, 2021) will be included. TSP-4 and TSP-1 will be measured in HD patients using a commercially available ELISA. PAD is diagnosed by the ankle-brachial index (ABI) We will measure related blood biomarkers such as serum hs-cTnT, N-terminal probrain natriuretic peptide, s-Klotho and FABP-4.
详细描述
Study Population and Data Source
This is a cross-sectional, single-center study which will be conducted in the Dialysis Center of Tungs' Taichung MetroHarbor Hospital (TTMHH) in the coastal region of central Taiwan. A cohort of 500 patients aged 20 or over, who have been on HD for at least 3 months prior to enrollment will be included. The medical charts of these patients are reviewed for eligibility identification, and should be compatible with the inclusion/exclusion criteria and enrolled in our analysis. The research was conducted ethically in accordance to the World Medical Association Declaration of Helsinki. Subjects provided written informed consent and the Local Ethical Committee approved the study.
The baseline data such as demographics, comorbidities, anthropometrics, and relevant laboratory data, clinical diagnosis of hear failure based on cardiac echocardiograhy measurements, and medication history will be collected. None of the patients were receiving blood transfusions, or intravenous iron therapy within two weeks before the time of inclusion. Doppler echocardiography using standardized equipment and complying with recommendations from the American Society of Echocardiography (2009)[20]. The biplane method of disks was used to measure left ventricular (LV) EF. Patients were eligible for the study if they had the New York Heart Association (NYHA) functional class II-IV; HFrEF and left ventricular EF (LVEF)≤40%. The characteristics of patients will be exclude from our study were (1) decompensated cirrhosis , (2) neoplastic diseases , (3) incomplete data, (4) receiving hemodialysis < 3 months and active infection.
Iron Status and Other Laboratory Measurements
Blood was drawn with EDTA anticoagulant in the morning after an overnight fast of at least 12 h before a dialysis session. The samples were separated via centrifugation (3000 rpm, 10 min) and immediately stored at -80°C for subsequent assays. Glucose, high-density lipoprotein cholesterol HDL), triglycerides and total cholesterol are all measured by standard assays using the analyzer. Low-density lipoprotein cholesterol (LDL) is measured by standard assay. High-sensitivity C-reactive protein (hsCRP) and are measured using standard nephelometry. Serum hs-cTnT was measured using a sandwich immunoassay method, a novel highly sensitive assay with a lower measurable limit of 3 ng/L.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes aged 20 years or over
- •Received stable hemodialysis at least 3 months.
- •Written informed consent.
排除标准
- •decompensated cirrhosis.
- •neoplastic diseases.
- •incomplete data.
- •receiving hemodialysis < 3 months and active infection.
结局指标
主要结局
Measures of iron status
时间窗: 1 years
indicating iron storage (ferritin), iron transport (transferrin saturation), regulator of systemic iron homeostasis (hepcidin) and iron demand (soluble transferrin receptor) ,Iron dysmetabolism potentially contributes to heart failure
次要结局
- Analysis of biomarkers of N-terminal probrain natriuretic peptide(1 years)
- Analysis of biomarkers of GDF-15(1 years)
- Analysis of biomarkers of Soluble ST2(1 years)
- Analysis of biomarkers of FABP-4(1 years)
- Analysis of biomarkers of Galectin-3(1 years)
- Analysis of biomarkers of hs-cTnT(1 years)
