Impact of Anemia Correction and Fibroblast Growth Factor 23 Levels in Left Ventricular Hypertrophy, and Early Endothelial Dysfunction in Chronic Kidney Disease, and Renal Transplant Patient
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- if change of in Hemoglobin level and correction of anemia associated with change in the left ventricular outcomes
研究概览
简要总结
The fibroblast growth factor-23-bone-kidney axis is part of newly discovered biological systems linking bone to other organ functions through a complex endocrine network that is integrated with the parathormone/vitamin D axis and which plays an equally important role in health and disease . Most of the known physiological function of fibroblast growth factor 23 to regulate mineral metabolism can be accounted for by actions of this hormone on the kidney.In a recent experimental study, fibroblast growth factor-23 was shown to cause pathological hypertrophy in rat cardiomyocytes by "calcineurin-nuclear factor of activated T cells" and treatment with fibroblast growth factor -blockers reduced left ventricular hypertrophy in experimental models of chronic renal failure.The current hypothesis is that, in healthy individuals, iron deficiency stimulates increased production of fibroblast growth factor23. At the same time, iron is thought to be the cofactor of enzymes taking part in the degradation of intact fibroblast growth factor-23 and thought to have a role in the excretion of degraded FGF-23 parts .Studies speculated that Angiotensin Converting Enzyme inhibitors may exert their anti-proteinuria effects at least in part by reducing serum fibroblast growth factor-23 levels although it is difficult from the results of this study to understand which comes first and brings about the other; decrease in proteinuria or fibroblast growth factor-23. Available evidence points to the deleterious effects of increased fibroblast growth factor-23 level in proteinuria, but the precise molecular mechanism still remains to be explored. An intricate and close association exists among parathormone, phosphorus, active vitamin D with FGF23, but the independent role of the latter on proteinuria is the least explored. Elaborately conducted studies that control effects of confounding factors adequately are needed to demonstrate the independent pathogenic role of FGF23.
详细描述
- To study the effect of anemia correction and left ventricular hypertrophy in Chronic Kidney Disease patients and renal transplant patients .
- To study the relation of fibroblast growth factor and Left ventricular hypertrophy in Chronic kidney disease and renal transplant patients.
- To study the relation between fibroblast growth factor 23 and early endothelial dysfunction in both Chronic kidney disease and renal transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients:
- •Above 18 years old
- •Diagnosed as CKD, and renal transplanted patients at Assiut University Hospital in the period 2017-2020 .
排除标准
- •Severely hypocalcaemic patients < 7mg/dl.
- •Severely hyperphosphatemic patients >7 mg/dl .
- •Uncontrolled hypertensive patients ( more than 3 antihypertensive drugs).
- •Uncontrolled diabetic patients HBA1C >8 .
- •Blood transfusion dependent
研究组 & 干预措施
CKD patients with different stages
- Full clinical history and through clinical examination.
- Full blood count at time of diagnosis and 3 months after initiation of treatment with iron and erythropoietin Stimulating agents.
- Iron study at time of diagnosis and 3 months after treatment .
- Serum calcium , phosphorus, intact Parathrmone hormone. 5-24- urinary proteins or Albumin Creatinine ratio every month (for 3 months )then every 3 months (1 st year), then annually.
6- Lipid profile . 7-Estimated glomerular filtration rate by MDRD equation .
干预措施: detailed echocardiography (Diagnostic Test)
CKD patients with different stages
- Full clinical history and through clinical examination.
- Full blood count at time of diagnosis and 3 months after initiation of treatment with iron and erythropoietin Stimulating agents.
- Iron study at time of diagnosis and 3 months after treatment .
- Serum calcium , phosphorus, intact Parathrmone hormone. 5-24- urinary proteins or Albumin Creatinine ratio every month (for 3 months )then every 3 months (1 st year), then annually.
6- Lipid profile . 7-Estimated glomerular filtration rate by MDRD equation .
干预措施: serum fibroblast growth factor-23 (Diagnostic Test)
CKD patients with different stages
- Full clinical history and through clinical examination.
- Full blood count at time of diagnosis and 3 months after initiation of treatment with iron and erythropoietin Stimulating agents.
- Iron study at time of diagnosis and 3 months after treatment .
- Serum calcium , phosphorus, intact Parathrmone hormone. 5-24- urinary proteins or Albumin Creatinine ratio every month (for 3 months )then every 3 months (1 st year), then annually.
6- Lipid profile . 7-Estimated glomerular filtration rate by MDRD equation .
干预措施: flow mediated dilatation of forearm (Diagnostic Test)
Newly renal transplanted patients .
- Full clinical history and through clinical examination.
- Pre transplant Serum calcium , phosphorus , I Parathrmone hormone , serial measures every / 3 months for 2 years.
- Pre-transplant full blood count serial measures every / 3 months for 2 years.
- Pre transplant serum Iron study and annually for 2 years.
- 24- urinary proteins or albumin-creatinine ratio every month (for 3 months )then every 3 months (1 st year), then annually.
- Post-transplant serum FGF-23 (as independent risk factor) at 6months.
- Different immunosuppressive protocols.
- Pre-transplant panel reactive antibody,donor-specific antibody
干预措施: serum fibroblast growth factor-23 (Diagnostic Test)
Newly renal transplanted patients .
- Full clinical history and through clinical examination.
- Pre transplant Serum calcium , phosphorus , I Parathrmone hormone , serial measures every / 3 months for 2 years.
- Pre-transplant full blood count serial measures every / 3 months for 2 years.
- Pre transplant serum Iron study and annually for 2 years.
- 24- urinary proteins or albumin-creatinine ratio every month (for 3 months )then every 3 months (1 st year), then annually.
- Post-transplant serum FGF-23 (as independent risk factor) at 6months.
- Different immunosuppressive protocols.
- Pre-transplant panel reactive antibody,donor-specific antibody
干预措施: detailed echocardiography (Diagnostic Test)
Newly renal transplanted patients .
- Full clinical history and through clinical examination.
- Pre transplant Serum calcium , phosphorus , I Parathrmone hormone , serial measures every / 3 months for 2 years.
- Pre-transplant full blood count serial measures every / 3 months for 2 years.
- Pre transplant serum Iron study and annually for 2 years.
- 24- urinary proteins or albumin-creatinine ratio every month (for 3 months )then every 3 months (1 st year), then annually.
- Post-transplant serum FGF-23 (as independent risk factor) at 6months.
- Different immunosuppressive protocols.
- Pre-transplant panel reactive antibody,donor-specific antibody
干预措施: flow mediated dilatation of forearm (Diagnostic Test)
结局指标
主要结局
if change of in Hemoglobin level and correction of anemia associated with change in the left ventricular outcomes
时间窗: measures at time of diagnosis then after 3 months
measure the left ventricular mass index (gm/m2)
the relationship between the FGF-23 and degree of left ventricular dysfunction
时间窗: measure at time of diagnosis
measure FGF-23 level in (pg/ml)
the relationship between FGF-23 level and early endothelial dysfunction
时间窗: at time of diagnosis in chronic kidney disease / after 6 months in renal transplant
change in arterial diameter in mm
次要结局
未报告次要终点
研究者
Omnia Mohammed Hashem
Assistant lecturer at Assiuy university- faculty of medicine-internal medicine department
Assiut University