Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: Injection Ferric Carboxymaltose: Dose will be based on the patient weight and Hb level. Given at baseline followed by a repeat dose after 4 weeks if needed.
Control Intervention1: Not a
Sponsors
Emcure Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Indian adult ( > 18 years of age) patients of either gender who are capable of complying with study protocol requirements. 2. Stable symptomatic ambulatory patients diagnosed with chronic heart failure of New York Heart Association (NYHA) class II â?? III and iron deficiency. Iron deficiency is diagnosed whenthe serum ferritin level is lessthan 100 μg/L or is between 100 and 299 μg/L when the transferrin saturation (TSAT) is less than 20%. 3. Patients ready to give informed consent for participation in study.
Exclusion criteria
Exclusion criteria: 1. Patients not willing to sign Informed Consent Form and provide medical data. 2. Hypersensitivity to ferric carboxymaltose injection. 3. Participation in any other clinical trial in the past 3 months. 4. Treatment with other IV Iron preparations within 4 weeks prior to study enrolment. 5. Any condition that, in the opinion of the investigator, does not justify the patientâ??s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the New York Heart Association (NYHA) class from baseline at Week 12 (+1 week).Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the New York Heart Association (NYHA) class, mean self-reported PatientGlobal Assessment (PGA) score and mean change in health-related quality of life [to be evaluated using Minnesota Living with Heart Failure Questionnaire Score] scoreTimepoint: 4 weeks;Change in the 2D Echocardiography findings & Ejection Fraction (%)Timepoint: Week 4 and 12;Mean change in the haematological parameters [serum ferritin, Haemoglobin (Hb), Total Iron Binding Capacity (TIBC) and Transferrin Saturation (TSAT)]Timepoint: Week 4 and 12;Mean change in health-related quality of life [to be evaluated using Minnesota Living with Heart Failure Questionnaire Score] scoreTimepoint: 12 weeks;Mean self-reported PGA score, health-related QOL score Timepoint: 12 weeks;Number and nature of serious and non-serious adverse events throughout study duration.Timepoint: 12 weeks;Rate of any hospitalization, rate of hospitalization for any cardiovascular reason, and rate of hospitalization due to worsening HFTimepoint: 12 weeks;Time to first hospitalization for any reason, time to first hospitalization for any cardiovascular reason and time to first hospitalization due to worsening HFTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Sanket Newale
Emcure Pharmaceuticals Limited
Outcome results
None listed