An observational study in Iron Deficiency Anemia, Coronary Artery Disease and Heart Failure With Preserved Ejection Fraction (HFPEF), sponsored by Alcea. Not yet recruiting at 5 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Alcea · Observational
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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:
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:
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
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's planned enrollment of 389 is above the median of 200 across 118 observational studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Alcea is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Absolute change in hemoglobin level at Week 12
Absolute change in hemoglobin level (g/L) from baseline (Visit 0) to Week 12 (Visit 2)
Time frame: From baseline (before treatment with Ferretab® comp.) to 12 weeks after treatment initiation (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)
Time frame: From baseline (before treatment with Ferretab® comp.) to 4 weeks after treatment initiation (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)
Time frame: Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
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))
Time frame: At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
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).
Time frame: At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Change in ferritin level
Change in ferritin level from baseline (Visit 0) at Week 4 (Visit 1) and Week 12 (Visit 2).
Time frame: 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
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)
Time frame: At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Change in RBC count
Change in red blood cell (RBC) count from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)
Time frame: From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in MCV
Change in mean corpuscular volume (MCV) from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)
Time frame: From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in MCH
Change in mean corpuscular hemoglobin (MCH) from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)
Time frame: From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in MCHC
Change in mean corpuscular hemoglobin concentration (MCHC) from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)
Time frame: 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
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.
Time frame: At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Change in resting HR
Change in resting HR from baseline (Visit 0) at Week 4 (Visit 1) and Week 12 (Visit 2).
Time frame: 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 dizziness
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Adherence to Ferretab® comp.
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.
Time frame: During the 12-week treatment period, assessed at Weeks 4, 8, and 12
Overall adherence to treatment with Ferretab® comp.
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.
Time frame: During the 12-week treatment period (overall assessment at Week 12)
Convenience of use of Ferretab® comp.
Subjective assessment of the convenience of use of Ferretab® comp. at Visit 2
Time frame: At Week 12 (Visit 2) after treatment initiation
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.
Of 49 non-industry observational studies under Anemia, Iron-Deficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's planned 8 months is below that.
Counting every sponsor, half of 54 studies reached it within 26 months; a quarter within 11 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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