Comparative outcomes of intravenous versus oral iron supplementation in acute decompensated heart failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- 1.Changes in new york heart
研究概览
简要总结
Heart failure represents a progressive clinical state characterized by significant morbidity and mortality .Iron deficiency , often accompanied by or independent of anemia, is prevalent among heart failure patients. Iron deficiency impacts prognosis, physical well being , exercise intolerance , hospitalization recurrence , and mortality rates.Clinical evidence form various large trials showed that parentral iron therapy for the correction of ID in patients with heart failure has a positive impact on morbidity , including functional improvement in QOL and HRQOL , 6MWT. We therefore plan to conduct an experimental study involving hospitalized patients with ADHF to evaluate the role of single dose parentral iron therapy prior to discharge in those patients who are found to have concurrent Iron deficieny. Comparing to other interventional trials , our study will use a simple dosing regimen of single dose parentral iron in addition to oral iron supplementation in iron deficient non- anemic patients with ADHF reagrdless of their LVEF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Hospitalized patients with acute decompensated heart failure irrespective of LVEF.
- •2.Patients with iron deficiency.
- •3.Patients able to complete six minute walk test ( 6MWT).
- •4.Individuals above 18 years of age.
排除标准
- •1.Serum ferritin concentrations above 400 microgram/dl.
- •2.Hemoglobin concentration less than 9 gram/dl.
- •4.Blood transfusions, intravenous iron therapy, or erythropoetin therapy within 3 months prior to enrolment.
- •5.Myocardial infarction in last 90 days.
- •6.Complex cyanotic congenital heart diseases.
- •7.Severe concomitant conditions like chronic kidney disease,renal dialysis, chronic lung disease chronic liver disease.
- •8.Hemolytic anemia or myelodysplastic order or abnormalities in iron storage such as hemochromatosis.
- •9.Recognized hematological, malignant or other active neoplasia.
- •10.Chemotherapy, radiation, or other immunosuppressive medication within three months of enrolment.
- •11.Pregnant women.
- •12.Serious medical conditions that the investigators determine make it impossible for participants to complete the trial.
结局指标
主要结局
1.Changes in new york heart
时间窗: At baseline , 3 months and 6 months
association (NYHA)
时间窗: At baseline , 3 months and 6 months
functional class at 3 and 6 months.
时间窗: At baseline , 3 months and 6 months
2.Change in ejection fraction
时间窗: At baseline , 3 months and 6 months
( by 2d ECHO ) at 6 months.
时间窗: At baseline , 3 months and 6 months
3.Change in 6MWT distance at 6
时间窗: At baseline , 3 months and 6 months
months .
时间窗: At baseline , 3 months and 6 months
4.Change in QOL as assessed by
时间窗: At baseline , 3 months and 6 months
the Minnesota living with
时间窗: At baseline , 3 months and 6 months
heart failure at 6 months .
时间窗: At baseline , 3 months and 6 months
5.Emergency revisit due to
时间窗: At baseline , 3 months and 6 months
ADHF.
时间窗: At baseline , 3 months and 6 months
6.Six months readmission due
时间窗: At baseline , 3 months and 6 months
to ADHF.
时间窗: At baseline , 3 months and 6 months
7.Six month mortality due to
时间窗: At baseline , 3 months and 6 months
8.Six month mortality due to
时间窗: At baseline , 3 months and 6 months
all cardiovascular causes
时间窗: At baseline , 3 months and 6 months
次要结局
未报告次要终点
研究者
Vinod kumar
Government Medical College and Hospital Chandigarh Sector32