The Effects of Intravenous Iron Therapy for Anemia Correction in Patients With Severe Chronic Heart Failure and Concomitant Moderate Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- percentage of patients with increased ejection fraction
研究概览
简要总结
Recently, growing body of evidence support the finding that anemia frequently occurs in patients with chronic heart failure (CHF). Chronic kidney disease (CKD), as well, is highly prevalent among heart failure patients, and both anemia and CKD are independently associated with increased mortality. A vicious circle is established with CHF causing both chronic renal insufficiency and anemia, and CKD further aggravating anemia which, in turn, worsens CHF and so on. Treatment of the anemia breaks this circle and improves the quality of life, cardiac and renal functions in patients with severe CHF.
Intravenous iron alone was proved to allow the maintenance of target hematocrit in one-third of chronic renal failure predialysis patients.
Based on these considerations, intravenous iron for anemia in patients with CHF and moderate CKD would represent a reasonable therapeutic approach.
The aim of the trial is to assess the efficiency of intravenous iron therapy in the management of mild to moderate anemia associated with CHF NYHA III class and concomitant moderate CKD.
详细描述
Intravenous iron administration in CHF patients with absolute or functional iron deficiency could correct their anemia, thus improving cardiac function judged by ejection fraction and NYHA functional class. If true, enhancement of cardiac output will increase oxygen delivery to tissues, including renal cortex. This might improve the renal functions and slow the rate of progression of CKD reflected by the slope of decline in glomerular filtration rate (GFR).
Since erythropoietin synthesis is located in peritubular fibroblasts from outer renal cortex, which is the most affected area during chronic hypoxia, increasing renal blood flow after anemia correction is expected to restore optimal erythropoietin production and normalize plasma Epo levels.
The primary objective is to assess the efficiency of intravenous iron therapy in the management of mild to moderate anemia associated with chronic heart failure NYHA III class and concomitant moderate chronic kidney disease.
The secondary objectives are to determine if the correction of anemia in these patients affects the cardiac function, the rate of progression of CKD and the plasma erythropoietin levels.
The study will be conducted in accordance with the Declaration from Helsinki and Tokyo, with the amendments from Venice (1983), after the approval by the local ethics committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persistent severe CHF: functional class NYHA III (marked limitation of physical activity - comfortable at rest, but less than ordinary activity results in shortness of breath and/or fatigue16); left ventricular ejection fraction (echocardiography) less than 40%; functional and systolic dysfunction criteria must be stable at two different examinations one month apart;
- •stable stage 3 chronic kidney disease: estimated GFR between 30-59mL/min/1.73m2 (mean value of three measurements within the last 8 weeks, separated from each other by at least one week); stable renal function (at least three different measurements within the past 8 weeks, separated from each other by at least one week; the difference between the highest and the lowest value should be less than 5mL/min/1.73m2)
- •mild to moderate anemia: hemoglobin levels < 12g/dL (mean value of three measurements within the last 8 weeks, separated from each other by at least one week) and stable (at least three measurements within the last 8 weeks; the difference between the highest and the lowest value should be less than 1.5g/dL);
- •iron deficiency: absolute (serum ferritin < 100ng/mL) or functional (serum ferritin 100-300ng/mL and transferrin saturation < 20%)
排除标准
- •evidence of active gastrointestinal or genital tract bleeding
- •folate or vitamin B12 deficiency
- •hypothyroidism
- •hemolytic anemia
- •any primary kidney diseases (glomerulonephritis, interstitial nephritis, cystic diseases)
- •systemic diseases with renal involvement (lupus erythematosus, vasculitis, amyloidosis)
- •renal artery stenosis (>70% lumen reduction)
- •diabetic nephropathy
- •severe malnutrition (SGA score C or lower)
- •active liver diseases
- •infectious conditions
- •malignancies
- •C-reactive protein > 12 mg/L
- •severe anemia (< 8.5g/dL)
- •blood transfusions in the preceding two months
- •iron therapy in the preceding three months
- •concomitant erythropoietin therapy
- •severe arterial hypertension (systolic BP >190 mm Hg and/or diastolic BP >115 mm Hg)
- •recent history (less than 3 months) of acute coronary syndrome
- •recent (less than 1 month) PCI
- •recent (less than 1 month) CABG surgery
- •active myocarditis
- •active endocarditis
- •more than mild valvar stenosis
- •more than moderate valvar (mitral or aortic) regurgitation
- •uncontrolled haemodynamically relevant atrial fibrillation/flutter
- •hypertrophic cardiomyopathy
- •acute and/or chronic pericarditis
- •cor pulmonale
- •participation in another study
研究组 & 干预措施
Group I
iv iron sucrose
干预措施: iron sucrose (Drug)
结局指标
主要结局
percentage of patients with increased ejection fraction
时间窗: 12 months
次要结局
- transferrin saturation(12 months)
- slope of GFR change(12 months)
- radial myocardial velocities(12 months)
- right ventricular function(12 months)
- the need for blood transfusions during the study period(12 months)
- serum ferritin level(12 months)
- global diastolic function(12 months)
- left ventricular mass index(12 months)
- major cardiovascular events (myocardial infarction, acute pulmonary edema, stroke)(12 months)
- hospital admissions(12 months)
- death of the patient (all causes deaths, cardiac deaths)(12 months)
- "death" of the kidney (initiation of renal replacement therapy)(12 months)
研究者
Liliana Garneata
Dr
Anemia Working Group Romania