Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT04063033
Eligibility Criteria:
Inclusion Criteria:
1. Patients admitted due to acute decompensated heart failure to internal medicine department H or cardiology department.
* Must meet two of the following criteria :
* NT pro BNP \> 300 pg/ml (\>800 pg/ml in the presence of Atrial Fibrillation).
* Peripheral pitting edema,
* Jugular Venous Distention,
* pulmonary edema/congestion according to physical examination or Chest X-ray.
* IV furosemide treatment on admission to ER or internal ward/cardiology department.
2. Hb level 8-14 mg/dl on admission.
3. Iron stores: Ferritin \<100 or Ferritin 100-300 and Transferrin saturation \< 20%.
4. No evidence of active bleeding.
5. Patient provided informed consent.
Exclusion Criteria:
1. Cardiogenic shock or any other condition requiring IV vasopressors.
2. Previous allergy or anaphylaxis due to IV Iron.
3. Active malignancy undergoing treatment.
4. Status post major surgery involving substantial blood loss in the past 3 months.
5. Indication for Blood transfusion.
6. Infection indicating IV antibiotics.
7. History of acquired iron overload; known haemochromatosis or first relatives with hemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
8. hemolytic anemia.
9. History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the upper limit of the normal range; chronic lung disease; myelodysplastic disorder; and known HIV/AIDS disease.
10. Recipient of immunosuppressive therapy or renal dialysis. History of erythropoietin, IV iron therapy, and blood transfusion in previous 30 days.
11. Unstable angina pectoris, as judged by the investigator; severe uncorrected valvular disease or left ventricular outflow obstruction; obstructive cardiomyopathy; uncontrolled fast atrial fibrillation or flutter (heart rate \>110 beats per minute \[bpm\]); uncontrolled symptomatic brady- or tachyarrhythmias.
12. Musculoskeletal limitation that, in the judgement of the investigator, would impair cardiopulmonary exercise testing.
13. Pregnant or breastfeeding.
14. Inability to comprehend study protocol.
15. Parallel participation in another clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04063033
Study Brief:
Protocol Section:
NCT04063033