Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron deficiency and heart failure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Charite University, Berlin, Germany; Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK); University of Göttingen
• Treatments: Iron

Criteria

Inclusion Criteria:

• Patients aged at least 18 years

• Patients with chronic heart failure present for at least 12 months

• Confirmed presence of iron deficiency

• Serum haemoglobin of 9.5 to 14.0 g/dL

Exclusion Criteria:

• Hypersensitivity to the active substance, to FCM or any of its excipients

• Known serious hypersensitivity to other parenteral iron products

• Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia

• Evidence of iron overload or disturbances in the utilisation of iron