Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency — IronEx  

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title: A Randomized Trial on Sequential Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency

Status Withdrawn

Clinical Trial Summary

It is the aim of the study to prove, if intravenous supplementation with ferric carboxymaltose in iron-deficient patients with heart failure with reduced ejection fraction (HFrEF) leads to better exercise training effects compared to exercise training without previous iron supplementation.

Clinical Trial Description

In patients with heart failure with reduced ejection fraction (HFrEF) exercise training (ET) is recommended. In iron-deficient HFrEF patients iron supplementation by ferric carboxymaltose (FCM) is recommended. Both treatment options (ET and iron supplementation) affect oxidative metabolism.

In this study iron-deficient HFrEF patients are included and randomly assigned to two study arms:

Study arm A: Intravenous iron supplementation with FCM, subsequent (after 2 months) ET program.

Study arm B: ET program, subsequent (after 2 months) intravenous iron supplementation with FCM.

Primary study endpoint is exercise capacity (Peak VO2). Secondary endpoints are 6-minute walking distance, NYHA class, echocardiographic parameters and the combined endpoint cardiovascular hospitalizations and death. ;

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Exercise Training
• Ferric Carboxymaltose
• Heart Failure
• Heart Failure With Reduced Ejection Fraction

• NCT number: NCT03803111
• Study type: Interventional
• Source: Herzzentrum Bremen
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2021
• Completion date: March 15, 2022