The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life

Exclusion Criteria

• •1. Haematological criteria: ferritin \>400ug/L; haemoglobin \<9.0 g/dL, or \>13.5 g/dL (for female), 14.5g/dL (for male).
• •2. Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \<15ml/min/1.73m2
• •3. Body weight\<35kg at randomization.
• •4. Heart failure was secondary to valvular diseases or congenital heart diseases.
• •5. History of acquired iron overload or hemochromatosis (or first-degree relative of haemochromatosis)
• •6. Known hypersensitivity reaction to any component of ferric derisomaltose (Monofer®) or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)).
• •7. Non-iron deficiency anaemia.
• •8. Already receiving erythropoiesis stimulating agents (ESA) or other iron supplements in previous 4 weeks prior to randomization.
• •9. Active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal haemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease) and history of malignant tumor.
• •10. Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean heart rate\> 100 beats / min at rest).
• •11. Known positive HBsAg and/or HCV RNA; known HIV positivity; chronic liver disease (including active hepatitis), hepatic sclerosis, ALT or AST \> 3x upper limit of normal.
• •12. Within 3 months of any of the following: acute myocardial infarction (AMI) or acute coronary syndrome (ACS), transient ischemic attack (TIA) or stroke, uncontrolled hypertension.
• •13. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) in the past 3 months; or planning cardiac surgery or revascularization.
• •14.6 minutes-walking distance\>500m at baseline. 15.Treated with long-term oral high-dose or steroid-immunosuppression therapy. 16.Investigator considers a possible alternative diagnosis to explain the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD).
• •17.Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.
• •18.Untreated hypothyroidism. 19.Currently enrolled in any other investigational device or drug study \<30 days prior to screening or received other investigational agent(s).