Oral Iron Therapy in Chronic Heart Failure Patients: a Randomized, Placebo-controlled and Double-blind Clinical Trial (Pilot Study) of Efficiency
试验速览
- 阶段
- 3 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Biochemical parameter of serum transferrin saturation
研究概览
简要总结
This study is design to evaluate the effectiveness of oral iron therapy in patients with heart failure and identify the central and peripheral mechanisms involved in the improvement of functional capacity after intervention. The investigation includes subjective and objective measures on exercise performance and heart function after intervention, and the tolerability of oral iron treatment.
详细描述
This is a placebo-controlled, double-blind and randomized clinical trial that will include patients with symptomatic stable chronic heart failure (New York Heart Association Functional Class II or III), with diagnosis of iron deficiency (ferritin <100 ng / dL or ferritin between 100 - 300 ng / dL and transferrin saturation <20%) followed in an outpatient clinic. The enrolled patients (n = 36) will be randomly allocated in the ratio 2:1 to treatment with 60 mg of elemental iron orally (n = 24) or placebo administration (n = 12), 3 times daily for 4 months. The primary outcome investigated will be an increase of the transferrin saturation ≥ 10 percentage points between baseline and after the intervention. Secondary outcomes of the study will be the change in iron stores, red blood cell indices, neurohumoral activation, left ventricular systolic function, functional capacity, mechanoreflex activity, and quality life score.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Both gender patients aged over 18 years;
- •Diagnosis of chronic heart failure (identified by the use of Framingham criteria) for ≥ 6 months;
- •New York Heart Association functional class II and III;
- •Left ventricular ejection fraction ≤ 45%
- •Regular attendance in an outpatient Heart Failure Clinic;
- •Adequate therapeutic drug for heart failure syndrome based on beta-adrenergic blocker, angiotensin converting enzyme inhibitor or angiotensin receptor blocker, and mineralocorticoid receptor blocker;
- •Evidence of iron deficiency in biochemical analyses: ferritin values < 100 ng/dL or between 100 ng/dL and 300 ng/dL, with transferrin saturation < 20%;
- •Hemoglobin value between 9,0 - 16 g/dL;
- •Provide written informed consent.
排除标准
- •Recent device implant (in the last 3 months) or perspective of device implantation (conventional or multisite pacing) in the next 6 months;
- •Known active infection, inflammatory disease or C-reactive protein > 20 mg/dL
- •Immunosuppressive therapy;
- •In use of erythropoietin and/or current treatment with oral or intravenous iron;
- •Clinically bleeding or blood transfusion in previous 3 months;
- •Renal failure on dialysis;
- •Hemoglobinopathies, hemochromatosis or active malignancy;
- •Unstable angina pectoris or clinically significant uncorrected valvular disease, except mitral and tricuspid regurgitation secondary to ventricular dilatation;
- •Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack within the last 3 months;
- •Uncontrolled arterial hypertension;
- •Evidence of comorbidity that features active systemic disease, i.e. liver disease, collagen disease and untreated hyperthyroidism or hypothyroidism;
- •Pregnant or lactating women;
- •Anaemia due to reasons other than iron deficiency (i.e. vitamin B12 deficiency);
- •Recent admission for decompensated heart failure (last 3 months).
研究组 & 干预措施
Placebo
干预措施: Placebo starch (Dietary Supplement)
Ferrous sulfate
干预措施: Ferrous sulfate (Dietary Supplement)
结局指标
主要结局
Biochemical parameter of serum transferrin saturation
时间窗: 4 months
次要结局
- Total score of physical, emotional, and overall dimensions domains of the Minnesota Living with Heart Failure Questionnaire(4 months)
- Biochemical parameter of serum ferritin(4 months)
- Ejection fraction of the left ventricle on doppler echocardiographic study(4 months)
- Blood pressure results during mechanoreflex evaluation(4 months)
- Biochemical parameter of hemoglobin in the hemogram analysis(4 months)
- Biochemical parameter of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) serum levels(4 months)
- Heart rate results during mechanoreflex evaluation(4 months)
- Volume of oxygen consumed at peak exercise during cardiopulmonary exercise testing(4 months)
- Volume of oxygen consumed results during mechanoreflex evaluation(4 months)
- Volume of oxygen consumed at anaerobic threshold during cardiopulmonary exercise testing(4 months)
研究者
Jaqueline Rodrigues de Souza Gentil
Master degree
University of Sao Paulo