A Study of ferric carboxymaltose treated chronic heart failure patients lacking iro
- Conditions
- Health Condition 1: null- Chronic Heart Failure with Iron Deficiency treated with Intravenous Ferric Carboxymaltose
- Registration Number
- CTRI/2018/02/011933
- Lead Sponsor
- Emcure Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Indian adult ( >18 years of age) patients of either gender who are capable of complying with study protocol
requirements
2. Stable ambulatory patients with chronic heart failure of New York Heart Association (NYHA) class I â?? IV and iron
deficiency. Iron deficiency is diagnosed when the serum ferritin level is less than 100 μg/L or is between 100 and 299
μg/L when the transferrin saturation (TSAT) is less than 20%
3. Patients treated with injection ferric carboxymaltose 1000 mg as per approved prescribing information.
4. Patients whose ejection fraction, serum ferritin and Hb levels are available at the start of FCM therapy.
1. Patients with incomplete health record as per the requirement of protocol
2. Patients not willing to sign Informed Consent Form and provide medical data
3. Pregnant and lactating women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method