The Effect of Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 主要终点
- Functional Capacity
研究概览
简要总结
The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia (IDA).
详细描述
The investigators conducted a double blind randomized controlled trial (RCT) enrolling 54 Heart Failure (HF) patients (LVEF < 50%) with IDA (Ferritin < 100 ng/mL or 100-300 ng/mL with Tsat < 20%) at outpatient clinic of National Cardiovascular Center Harapan Kita from January to July 2016. Patients were randomized 1:1 to received FS or placebo for 90 days, the investigators then evaluated the change in 6-Minute Walking Test (6MWT) distance as primary end-point and changes on N-Terminal-pro Brain Natriuretic Peptide (NT-proBNP) and post 6MWT serum lactate levels as secondary end-points.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 year old
- •Systolic heart failure patients without clinical sign of decompensation at outpatient clinic
- •New York Heart Association (NYHA) functional class II-III able to perform 6MWT
- •LVEF < 50%
- •On heart failure therapy
- •Haemoglobin (Hb) < 13 gr/dL (male); Hb < 12 gr/dL (female) and > 8 gr/dL
- •Ferritin < 100 µg/L or Ferritin 100-300 µg/L dengan Transferrin saturation (Tsat) < 20%
- •Agree to participate
排除标准
- •History of : active bleeding,infection, malignancy, haematological abnormality, peptic ulcer
- •History of myocardial revascularization (CABG/PCI) within 3 month
- •Acute Coronary Syndrome (ACS), stroke,Transient Ischemic Attack (TIA) within 3 month
- •Know to have allergic reaction to Ferrous sulfate
- •History of intravenous iron administration within 1 month
- •Permanent Pace Maker(PPM)/Implantable Cardiac Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT)
- •estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2
- •NT-proBNP > 4000 pg/ml (for patients without baseline data) or decreased level of NT-proBNP < 30% from baseline
- •Increase level of serum alanine aminotransferase (ALT)/ serum aspartate aminotransferase (AST)> 3x normal value
- •Moderate to severe primary valvular heart disease
- •Congenital heart disease
- •Right heart failure due to primary pulmonary hypertension, cor pulmonale, Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH)
研究组 & 干预措施
Control Group
Systolic heart failure patients received placebo oral capsule t.i.d for 90 days
干预措施: Placebo Oral Capsule (Drug)
Treated Group
Systolic heart failure patients received Ferrous Sulfate 200 mg t.i.d for 90 days
干预措施: Ferrous Sulfate (Drug)
结局指标
主要结局
Functional Capacity
时间窗: 90 days
Six Minute Walk Test (meter)
次要结局
- Haemoglobin(90 days)
- N Terminal-pro Brain Natriuretic Peptide(90 days)
- Echocardiography parameters(90 days)
- Ferritin(90 days)
- Transferrin saturation(90 days)
研究者
Lita Dwi Suryani
Principal Investigator
National Cardiovascular Center Harapan Kita Hospital Indonesia