Assessment of Clinical Profile of Patients of Chronic Heart Failure with Iron Deficiency Treated with Intravenous Ferric Carboxymaltose 1000 mg:- PRIDE-HF India Study

Iron deficiency is estimated to affect 37–61% of patients with chronic heart failure (CHF). The diagnosis of iron deficiency in CHF is complicated by the fact that the key manifestations of CHF (fatigue, exercise intolerance) are the same as those of iron deficiency (ID). In CHF, iron deficiency has been shown to adversely impact exercise capacity and quality of life independently of anemia and predicts worse outcomes. ID has shown to be an independent predictor of mortality in patients with CHF. Iron deficiency, regardless of haemoglobin level, is an indication for iron supplementation in symptomatic patients As limited data is available on clinical profile of Indian patients of CHF with iron deficiency who are treated with intravenous ferric carboxymaltose (IV FCM), this study has been planned. The objective of this study is to understand the disease profile and clinical profile of patients diagnosed with CHF with iron deficiency and treated with IV FCM 1000 mg. The study design will be a cross-sectional, multi-centre, non-interventional study of adult Indian patients diagnosed with chronic heart failure with iron deficiency and prescribed with injection ferric carboxymaltose 1000 mg as per approved prescribing information. During screening of the patients, those found to be eligible as confirmed by inclusion/exclusion criteria will be enrolled into the study. Those willing to participate and provide their health record for the purpose of study will be asked to sign the Informed Consent Form.

Patient’s demographic characteristics, disease profile, significant medical history, treatment details and concomitant medications details will be recorded by the Investigator in the Case Report Form (CRF). No examination or investigations beyond that normally required in routine clinical practice are needed to be done for the purpose of this study. No follow-up of the patients will be done. Patient’s ejection fraction, serum ferritin, transferrin saturation, Hemoglobin done at the time of initiation of treatment with injection ferric carboxymaltose will also be recorded in to CRF.