Coronary Artery Disease, Heart Failure With Preserved Ejection Fraction (HFPEF), Iron Deficiency Anemia
Conditions
Keywords
Ferretab® comp., Ferrous fumarate, Folic acid, Iron replacement therapy, Oral iron therapy, Exercise tolerance, Sideropenic syndrome, Safety of iron therapy
Brief summary
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.
Detailed description
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. Indications: Treatment of latent iron deficiency and iron deficiency anemia, combined with folic acid deficiency, including during pregnancy. Ferretab® comp. is registered in: Russia, Belarus, Kazakhstan, Kyrgyzstan, Armenia, Latvia, Lithuania, Romania, Austria, Uzbekistan
Interventions
None listed
Sponsors
Alcea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in hemoglobin level at Week 12 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in hemoglobin level at Week 4 | From baseline (before treatment with Ferretab® comp.) to 4 weeks after treatment initiation (Visit 1) | Absolute change in hemoglobin level (g/L) from baseline (Visit 0) to Week 4 (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 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 | At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation | 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 | At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation | Proportion of patients achieving the target ferritin level (40 ng/mL or more) at Week 4 (Visit 1) and Week 12 (Visit 2). |
| Change in ferritin level | From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2) | Change in ferritin level from baseline (Visit 0) at Week 4 (Visit 1) and Week 12 (Visit 2). |
| Proportion of patients with an increase in hematocrit | At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation | Proportion of patients with a 3% increase in hematocrit level (Hct) from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2) |
| 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 red blood cell (RBC) count from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (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 mean corpuscular volume (MCV) from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (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 mean corpuscular hemoglobin (MCH) from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (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) | Change in mean corpuscular hemoglobin concentration (MCHC) from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (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 sideropenic syndrome assessed by the doctor at Week 4 (Visit 1) and Week 12 (Visit 2), expressed as the proportion of patients with a reduction in the syndrome severity. |
| 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 resting HR from baseline (Visit 0) at Week 4 (Visit 1) and Week 12 (Visit 2). |
| 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) | Dizziness severity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 mm indicates no dizziness and 100 mm indicates the worst possible dizziness. A decrease in VAS score represents an improvement in dizziness severity. |
| 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) | Edema severity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 mm indicates no edema and 100 mm indicates the worst possible edema. A decrease in VAS score represents an improvement in edema severity. |
| 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) | Dyspnea severity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 mm indicates no dyspnea and 100 mm indicates the worst possible dyspnea. A decrease in VAS score represents an improvement in dyspnea severity. |
| 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) | Fatigue severity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 mm indicates no fatigue and 100 mm indicates the worst possible fatigue. A decrease in VAS score represents an improvement in fatigue severity. |
| 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) | Exercise tolerance will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 mm indicates no limitations during exercise and 100 mm indicates the greatest possible limitations during exercise. A decrease in the VAS score indicates an improvement in exercise tolerance. |
| Adherence to Ferretab® comp. | During the 12-week treatment period, assessed at Weeks 4, 8, and 12 | Adherence will be assessed at Weeks 4, 8, and 12 using a study-specific 4-category ordinal adherence scale included in the Patient Diary (4 = frequently missed doses; 3 = sometimes missed doses; 2 = rarely missed doses; 1 = no missed doses). Lower scores indicate better adherence. Results will be presented as n (%) in each category. |
| Overall adherence to treatment with Ferretab® comp. | During the 12-week treatment period (overall assessment at Week 12) | Overall adherence will be calculated as the median of three available assessments, the lower (worse) score if two assessments are available, or the single available score at Weeks 4, 8, and 12 by study-specific 4-category ordinal scale (4 = frequently missed doses; 3 = sometimes missed doses; 2 = rarely missed doses; 1 = no missed doses). Results will be presented as n (%) in each category. |
Countries
Russia
Contacts
CONTACTKirill Sokolov
Outcome results
None listed