A Multicenter, Non-Interventional, Prospective Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Capsules) Effects in Adult Patients With Iron Deficiency Anemia and Cardiovascular Diseases in Real-World Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 389
- 试验地点
- 5
- 主要终点
- Absolute change in hemoglobin level at Week 12
研究概览
简要总结
The goal of this observational study is to learn how well Ferretab® comp. works and how safe it is for adults with iron deficiency anemia and cardiovascular disease who are receiving treatment as part of their usual medical care. The main questions it aims to answer are:
- Does treatment with Ferretab® comp. improve anemia?
- Does treatment with Ferretab® comp. improve heart-related symptoms, exercise tolerance, and overall well-being?
- What side effects do participants have while taking Ferretab® comp.?
This is a non-interventional study. Participants will receive Ferretab® comp. because their doctor has already decided to prescribe it as part of routine medical care. Ferretab® comp. is an oral medicine that contains iron (as iron fumarate) and folic acid. The study will not change their treatment.
Participants will:
- Take Ferretab® comp. for 12 weeks as prescribed by their doctor.
- Attend study visits at the start of treatment, after about 4 weeks, and after about 12 weeks.
- Have routine blood tests and health assessments during the study.
- Report any side effects and record information in a patient diary.
- Answer questions about their symptoms, exercise tolerance, and how easy the treatment is to use.
详细描述
Iron deficiency anemia (IDA) is a common condition that may worsen symptoms and outcomes in people with cardiovascular diseases (CVDs). Adequate treatment of iron deficiency may improve hematologic parameters and reduce symptoms associated with anemia. This post-authorization, non-interventional study is designed to evaluate the effectiveness and safety of Ferretab® comp. in adults with IDA and concomitant cardiovascular disease treated under routine clinical practice conditions.
As this is a non-interventional study, all diagnostic and therapeutic procedures will be performed in accordance with routine clinical practice and the approved Summary of Product Characteristics. No additional diagnostic or therapeutic procedures will be performed solely for study purposes.
The study is intended to provide real-world evidence on the effectiveness, safety, and use of Ferretab® comp. in adults with iron deficiency anemia and concomitant cardiovascular disease treated in routine clinical practice.
Composition of Ferretab® comp.
Active ingredients: iron fumarate and folic acid. Each prolonged-release capsule contains 3 mini-tablets with iron fumarate and 1 mini-tablet with folic acid, which contain: iron fumarate equivalent to 50 mg of iron, folic acid - 500 mcg.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female patients aged 18 years or older.
- •Diagnosis of mild to moderate iron deficiency anemia (IDA), defined as hemoglobin 70-129 g/L in men or 70-119 g/L in women and ferritin <30 ng/mL, with laboratory results obtained within 14 days before Visit
- •Presence of at least 1 chronic CVD, defined as coronary artery disease or congestive heart failure with preserved ejection fraction (left ventricular ejection fraction ≥50%; NYHA Functional Class I-II).
- •Ability to understand the study requirements and provide written informed consent to participate in the study, including consent for the use and transfer of health information relevant to the study.
- •The physician has decided to prescribe Ferretab® comp. as IDA treatment of IDA at a dose of 2 capsules per day.
- •Signed Informed Consent Form.
排除标准
- •Hypersensitivity to any component of Ferretab® comp.
- •Any contraindication to the use of Ferretab® comp. as specified in the Summary of Product Characteristics.
- •Use of any other iron-containing medicinal products within 3 months prior to study enrollment (including oral iron preparations, intravenous iron formulations, or mineral/supplement products containing a therapeutic dose of iron).
- •Severe anemia (hemoglobin concentration <70 g/L).
- •Confirmed or suspected diagnosis of anemia of chronic disease.
- •Pregnancy or breastfeeding.
- •Surgery planned to be performed during the study period.
- •CVD or any other chronic disease in the stage of decompensation.
- •Congestive heart failure with reduced ejection fraction (NYHA Functional Class III-IV (see Appendix 2) and/or ejection fraction <50%).
- •Severe chronic kidney disease (Stage IV-V chronic kidney disease, or patients receiving hemodialysis or peritoneal dialysis).
- •Severe chronic liver disease (Child-Pugh Class B or C liver cirrhosis, active hepatitis, or ALT/AST >3 × the upper limit of normal).
- •Active malignancy (patients receiving chemotherapy, radiotherapy, or immunotherapy).
- •Anemias unrelated to iron deficiency, as well as other chronic hematologic disorders (thalassemia, aplastic anemia, myelodysplastic syndrome, and autoimmune hemolytic anemia).
- •Evidence of anemia of inflamation.
- •Gastrointestinal malabsorption disorders (active celiac disease, small bowel resection, short bowel syndrome, or severe flare of Crohn's disease or ulcerative colitis).
- •Recent bleeding, including gastrointestinal bleeding within 3 months before the study entry, surgery associated with blood loss within 8 weeks before the study entry, hemorrhagic stroke within 3 months before the study entry.
- •Blood transfusion within 3 months before the study entry.
- •Severe psychiatric disorders that impair the patient's ability to comply with the Protocol requirements and/or to provide valid informed consent.
- •Planned use, at the time of the study entry, of any medication or procedure listed as prohibited therapy.
研究组 & 干预措施
Ferretab® comp.
Adults with iron deficiency anemia (IDA) and concomitant cardiovascular disease (CVD) receiving treatment with Ferretab® comp. under routine clinical practice. Ferretab® comp. is an oral capsule containing iron fumarate (equivalent to 50 mg elemental iron) and 500 mcg folic acid.
结局指标
主要结局
Absolute change in hemoglobin level at Week 12
时间窗: From baseline (before treatment with Ferretab® comp.) to 12 weeks after treatment initiation (Visit 2)
Absolute change in hemoglobin level (g/L) from baseline (Visit 0) to Week 12 (Visit 2)
次要结局
- Absolute change in hemoglobin level at Week 4(From baseline (before treatment with Ferretab® comp.) to 4 weeks after treatment initiation (Visit 1))
- Proportion of patients achieving the target hemoglobin level(Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation)
- Proportion of patients achieving treatment response(At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation)
- Proportion of patients achieving the target ferritin level(At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation)
- Change in ferritin level(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Proportion of patients with an increase in hematocrit(At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation)
- Change in RBC count(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in MCV(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in MCH(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in MCHC(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Proportion of patients with a reduction in the syndrome severity(At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation)
- Change in resting HR(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in the VAS score for dizziness(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in the VAS score for edema severity(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in the VAS score for dyspnea(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in the VAS score for fatigue(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in the VAS score for exercise tolerance(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Total adherence to treatment with Ferretab® comp.(During the 12-week treatment period (overall assessment at Week 12))
- Adherence to Ferretab® comp.(During the 12-week treatment period, assessed at Weeks 4, 8, and 12)
- Change in the Visual Analog Scale score for dizziness(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in the Visual Analog Scale score for edema severity(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in the Visual Analog Scale score for dyspnea(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in the Visual Analog Scale score for fatigue(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Change in the Visual Analog Scale score for exercise tolerance(From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2))
- Overall adherence to treatment with Ferretab® comp.(During the 12-week treatment period (overall assessment at Week 12))