NCT03991000

Iron in Patients With Cardiovascular Disease

Investigator-initiated, Randomized, Double-blind, Controlled, Multi-center Trial of Intravenous Iron in Patients With Cardiovascular Disease and Concomitant Iron Deficiency

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Dr. med. Mahir Karakas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is now recognized that iron deficiency in cardiovascular disease contributes to impaired clinical outcome.

Detailed description

The clinical trial is designed as a prospective, multi-centre, double-blind, randomised, controlled, interventional trial to investigate whether a therapy with i.v. iron (iron carboxymaltose) compared to saline can improve functional status across a subset of cardiovascular disease -namely acute myocardial infarction, atrial fibrillation, and heart failure with reduced ejection fraction. Iron administration will be carried out according to summary of product characteristics. Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg iron carboxymaltose (over 15 minutes), except when haemoglobin is \> 16.0 g/dL or ferritin is \> 600 µg/L.

Conditions

• Cardiovascular Diseases
• Anemia, Iron-deficiency
• Acute Myocardial Infarction
• Atrial Fibrillation
• Systolic Heart Failure

Interventions

Type	Name	Description
DRUG	Ferric carboxymaltose	Intravenous iron
DRUG	Saline	Saline application according to dosing rules of iron.

Timeline

• Start date: 2019-02-28
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2019-06-19
• Last updated: 2023-12-27

Locations

3 sites across 1 country: Germany