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.
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 0.
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.
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).
Men and women aged 18 years and older with mild to moderate IDA and CVD (coronary artery disease (CAD) and congestive heart failure (CHF) with preserved ejection fraction), who have been prescribed Ferretab® comp. as part of routine clinical practice
Cohort
Prospective
Not listed
Absolute change in hemoglobin level at Week 12
Absolute change in hemoglobin level (g/L) from baseline (Visit 0) to Week 12 (Visit 2)
Absolute change in hemoglobin level at Week 4
Absolute change in hemoglobin level (g/L) from baseline (Visit 0) to Week 4 (Visit 1)
Proportion of patients achieving the target hemoglobin level
Proportion of patients achieving the target hemoglobin level (120-140 g/L in women or 130-160 g/L in men) at Week 4 (Visit 1) and Week 12 (Visit 2)
Proportion of patients achieving treatment response
Proportion of patients achieving treatment response (an increase in hemoglobin level by 10 g/L or more at Week 4 (Visit 1) and 20 g/L or more at Week 12 (Visit 2))
Proportion of patients achieving the target ferritin level
Proportion of patients achieving the target ferritin level (40 ng/mL or more) at Week 4 (Visit 1) and Week 12 (Visit 2).
Convenience of use of Ferretab® comp.
Subjective assessment of the convenience of use of Ferretab® comp. at Visit 2
This trial is not recruiting at the moment. You can still explore other options: