Health Condition 1: - Health Condition 2: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: Ferrous Carboxymaltose: Dose- 1000mg
Frequency- single time
Route of administration- intravenous in 100ml Normal saline
Duration - over 30 minutes
Control Intervention1: Normal Saline
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: I) Age >18 years. ii) NYHA class III and IV. iii)Bilateral B-lines on lungs ultrasonography. iv) Left ventricular ejection fraction less than 50%. v) Serum ferritin level less than 100 ng/ml or serum ferritin more than 200ng/ml with transferrin saturation less than 20%. vi)Patients / Legally authorised representative willing to give valid consent.
Exclusion criteria
Exclusion criteria: I) Individuals/ legally authorized representative unwilling to give written consent for participation in the study. ii)Acute coronary syndrome OR Acute myocardial infarction within one month. iii) Rheumatic valvular heart disease. iv) History of blood transfusion in last one month. v) known history of hypersensitivity to any component of intravenous iron. vi) patient on mechanical ventilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I) To study clinical improvement using NYHA grading in an iron deficient patient with Acute Decompensated Heart Failure after intravenous iron therapy. II) To evaluate the rate of rehospitalization within one month after intravenous iron therapy in iron group versus placebo group in an iron deficient patient with Acute Decompensated Heart Failure. Timepoint: one and half year | — |
Secondary
| Measure | Time frame |
|---|---|
| I) To study effect of intravenous iron therapy on ejection fraction improvement in an iron deficient patient with Acute Decompensated Heart Failure at one month. ii) To study effect of intravenous iron on mortality at one month in an iron deficient patient with Acute Decompensated Heart Failure. Timepoint: one and half year | — |
Countries
India
Contacts
Public ContactMukesh kumar Jha
Department of emergency medicine AIIMS New Delhi
Outcome results
None listed