Non-Interventional Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Capsules) Effects in Adult Patients With Iron Deficiency Anemia and Cardiovascular Disease

Korábbi kezelés

• 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).
• Surgery planned to be performed during the study period.
• Severe chronic kidney disease (Stage IV-V chronic kidney disease, or patients receiving hemodialysis or peritoneal dialysis).
• Active malignancy (patients receiving chemotherapy, radiotherapy, or immunotherapy).
• 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.
• Planned use, at the time of the study entry, of any medication or procedure listed as prohibited therapy.

Más betegség

• Hypersensitivity to any component of Ferretab® comp.
• Confirmed or suspected diagnosis of anemia of chronic disease.
• CVD or any other chronic disease in the stage of decompensation.
• Anemias unrelated to iron deficiency, as well as other chronic hematologic disorders (thalassemia, aplastic anemia, myelodysplastic syndrome, and autoimmune hemolytic anemia).
• Gastrointestinal malabsorption disorders (active celiac disease, small bowel resection, short bowel syndrome, or severe flare of Crohn's disease or ulcerative colitis).
• Severe psychiatric disorders that impair the patient's ability to comply with the Protocol requirements and/or to provide valid informed consent.

Laborértékek

• Severe anemia (hemoglobin concentration <70 g/L).
• Congestive heart failure with reduced ejection fraction (NYHA Functional Class III-IV (see Appendix 2) and/or ejection fraction <50%).
• Severe chronic liver disease (Child-Pugh Class B or C liver cirrhosis, active hepatitis, or ALT/AST >3 × the upper limit of normal).

Egyéb

• Any contraindication to the use of Ferretab® comp. as specified in the Summary of Product Characteristics.
• Pregnancy or breastfeeding.
• Evidence of anemia of inflamation.

• 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.
• 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.