Non-Interventional Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Caps… (NCT07753031) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Non-Interventional Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Capsules) Effects in Adult Patients With Iron Deficiency Anemia and Cardiovascular Disease
Russia389 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute change in hemoglobin level at Week 12
Timeframe: From baseline (before treatment with Ferretab® comp.) to 12 weeks after treatment initiation (Visit 2)