Clinical Trial

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

Study acronym: PROMETHEUS
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07753031
Lead Sponsor Alcea
Conditions Iron Deficiency Anemia, Coronary Artery Disease, Heart Failure With Preserved Ejection Fraction (HFPEF)
Enrollment 389 participants
Start Date 2026-09
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-07