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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Iron Deficiency Anemia; Heart Failure With Preserved Ejection Fraction (HFPEF)

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

• Study Type: Observational
• Enrollment (Estimated): 389

Contacts and Locations

• Study Contact: Name: Kirill Sokolov; Phone Number: +7 985 610-44-61; Email: kirill.sokolov@alceapharma.ru

Study Locations

• Russia
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 194358
      • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
      • Contact: Diana Alpenidze, MD, PhD; Phone Number: +7 911 760-51-15; Email: d.alpenidze@mail.ru
      • Principal Investigator: Diana Alpenidze, MD, PhD
    • Saint Petersburg, Sankt-Peterburg, Russia, 197348
      • Surgical Clinic LLC
      • Contact: Irina Kraeva; Phone Number: +7 999 209-39-34; Email: irina.kraeva@astartaclinic.ru
      • Principal Investigator: Polina Ermakova, MD
    • Saint Petersburg, Sankt-Peterburg, Russia, 198328
      • Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 106"
      • Contact: Danila Chizhov, MD; Phone Number: +7 921 948-44-38; Email: danila@chizhov.me
      • Principal Investigator: Vyacheslav Kubalov, MD
    • Saint Petersburg, Sankt-Peterburg, Russia, 199397
      • Astarta LLC
      • Contact: Irina Kraeva; Phone Number: +7 999 209-39-34; Email: irina.kraeva@astartaclinic.ru
      • Principal Investigator: Dmitriy Kositsyn, MD
  • Vsevolozhsk
    • Vsevolozhsk, Vsevolozhsk, Russia, 188643
      • Vsevolozhsk Clinical Interdistrict Hospital
      • Contact: Eduard Umanets, MD; Phone Number: +7 981 722-20-28; Email: edward.umanets@gmail.com
      • Principal Investigator: Inna Parsapina, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in hemoglobin level at Week 12	Absolute change in hemoglobin level (g/L) from baseline (Visit 0) to Week 12 (Visit 2)	From baseline (before treatment with Ferretab® comp.) to 12 weeks after treatment initiation (Visit 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in hemoglobin level at Week 4	Absolute change in hemoglobin level (g/L) from baseline (Visit 0) to Week 4 (Visit 1)	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)	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))	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).	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).	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)	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)	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)	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)	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)	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.	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).	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	Change in the VAS score for dizziness from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2).	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	Change in the VAS score for edema severity from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)	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	Change in the VAS score for dyspnea from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)	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	Change in the VAS score for fatigue from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)	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	Change in the VAS score for exercise tolerance from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)	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 to Ferretab® comp., assessed using Patient Diary data and an ordinal categorical scale during the course of treatment at Weeks 4, 8, and 12	During the 12-week treatment period, assessed at Weeks 4, 8, and 12
Total adherence to treatment with Ferretab® comp.	Total adherence to treatment with Ferretab® comp., assessed using Patient Diary data and an ordinal categorical scale	During the 12-week treatment period (overall assessment at Week 12)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Convenience of use of Ferretab® comp.	Subjective assessment of the convenience of use of Ferretab® comp. at Visit 2	At Week 12 (Visit 2) after treatment initiation

Collaborators and Investigators

• Sponsor: Alcea

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 4, 2026
• First Submitted That Met QC Criteria: August 4, 2026
• First Posted (Actual): August 7, 2026

Study Record Updates

• Last Update Posted (Actual): August 7, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Folic acid; Exercise tolerance; Ferrous fumarate; Oral iron therapy; Iron replacement therapy; Ferretab® comp.; Sideropenic syndrome; Safety of iron therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Hematologic Diseases; Anemia; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Coronary Artery Disease; Anemia, Iron-Deficiency
• Other Study ID Numbers: FER-007-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No