Prospective ObseRvational Study to Assess Effectiveness and Safety of IntravenousFerric Carboxymaltose 1000 mg in Patients of Chronic Heart Failure with IronDeficiEncy - PRIDE-HF Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in the New York Heart Association (NYHA) class from baseline at Week 12 (+1 week).
研究概览
简要总结
In patients with chronic diseases, especially those having complex inflammatory disorder, a multidisciplinary approach is needed to maintain quality of life (QoL) and improve clinical outcomes. Iron deficiency is one such clinical condition which affects more than 2 billion people globally. Ferric carboxymaltose (FCM) is used for rapid and high-dose replenishment of depleted iron stores. The proposed study is a non-interventional observational study which aims to collect data reflectingthe real-world experience with Ferric carboxymaltose (FCM) in the post-approval setting to expandtheir understanding of its clinical effectiveness and safety in patients with stable chronic heart failurewith anaemia. Data will be collected in about hundred patients from multiple centers. Patients will be followed for 12 weeks to collect information on improvement in symptoms, cardiac function, quality of life, adverse events etc.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Indian adult (> 18 years of age) patients of either gender who are capable of complying with study protocol requirements.
- •Stable symptomatic ambulatory patients diagnosed with chronic heart failure of New York Heart Association (NYHA) class II – III and iron deficiency.
- •Iron deficiency is diagnosed whenthe serum ferritin level is lessthan 100 μg/L or is between 100 and 299 μg/L when the transferrin saturation (TSAT) is less than 20%.
- •Patients ready to give informed consent for participation in study.
排除标准
- •Patients not willing to sign Informed Consent Form and provide medical data.
- •Hypersensitivity to ferric carboxymaltose injection.
- •Participation in any other clinical trial in the past 3 months.
- •Treatment with other IV Iron preparations within 4 weeks prior to study enrolment.
- •Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study.
结局指标
主要结局
Change in the New York Heart Association (NYHA) class from baseline at Week 12 (+1 week).
时间窗: 12 weeks
次要结局
- Mean self-reported PGA score, health-related QOL score
- Mean change in health-related quality of life [to be evaluated using Minnesota Living with Heart Failure Questionnaire Score] score(12 weeks)
- Number and nature of serious and non-serious adverse events throughout study duration.(12 weeks)
- Rate of any hospitalization, rate of hospitalization for any cardiovascular reason, and rate of hospitalization due to worsening HF(12 weeks)
- Time to first hospitalization for any reason, time to first hospitalization for any cardiovascular reason and time to first hospitalization due to worsening HF(12 weeks)
- Mean change in the haematological parameters [serum ferritin, Haemoglobin (Hb), Total Iron Binding Capacity (TIBC) and Transferrin Saturation (TSAT)](Week 4 and 12)
- Change in the New York Heart Association (NYHA) class, mean self-reported PatientGlobal Assessment (PGA) score and mean change in health-related quality of life [to be evaluated using Minnesota Living with Heart Failure Questionnaire Score] score(4 weeks)
- Change in the 2D Echocardiography findings & Ejection Fraction (%)(Week 4 and 12)