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临床试验/CTRI/2025/08/093719
CTRI/2025/08/093719尚未招募3 期

efficacy of intravenous iron therapy vs oral iron therapy on haemoglobin, exercise tolerance, cardiovascular risk and quality of life in patients having heart failure in mild to moderate iron deficiency anaemia

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月28日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To study efficacy of intravenous iron therapy vs oral iron therapy in patients having heart failure with mild to moderate iron

研究概览

简要总结

This is an open-label randomized controlled trial that aims to evaluate the efficacy of intravenous (IV) iron therapy versus oral iron supplementation in heart failure (HF) patients with mild to moderate iron deficiency anemia.The study will be carried out patients who are admitted Medicine ward  of Acharya Vinoba Bhave Rural Hospital (AVBRH) of Jawaharlal Nehru Medical College, Sawangi, Wardha from 2023 to 2025.Heart failure (HF) is a prevalent condition, especially among adults over 65, leading to significant morbidity and mortality. A common comorbidity in these patients is iron deficiency anemia, with prevalence estimates ranging from 4% to 30%. This comorbidity exacerbates clinical outcomes, increasing hospitalizations, impairing exercise capacity, diminishing quality of life, and elevating mortality risk. Data will be collected through face-to-face interviews with heart failure patients experiencing iron deficiency anemia at AVBRH, following written consent. Two groups will be formed: one receiving intravenous iron therapy (Inj ferric carboxymaltose) and the other oral iron therapy.  Baseline assessment of Hemoglobin levels, serum ferritin, serum iron, New York Heart Association (NYHA) classification, Six-Minute Walk Test (6MWT), and quality of life evaluation using the WHOQOL-100 questionnaire and follow up will be done at 3 months and 9 months. Adverse effects will be monitored throughout the study.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients with heart failure fulfilling the Framinghams criteria.
  • Patients with mild to moderate IDA i.e. Hb levels between 8-10 gm%.

排除标准

  • Patients with acute or decompensated heart failure ,severe iron deficiency anemia , aplastic anemia, anemia of chronic disease , sideroblastic anemia.
  • Patients with creatinine more than 2.

结局指标

主要结局

To study efficacy of intravenous iron therapy vs oral iron therapy in patients having heart failure with mild to moderate iron

时间窗: At baseline , 3 months and 9 months

次要结局

  • To study effect of intravenous iron vs oral iron on hemoglobin, exercise tolerance and quality of life in patients with heart failure with mild to moderate anemia.(At baseline , 3 months and 9 months)

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Other [Datta Meghe Institute of Higher Education and Research]
责任方
Principal Investigator
主要研究者

Dr.Shikha Mundra

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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