Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
A Randomized Trial on Sequential Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
Lead SponsorHerzzentrum Bremen
Indication/ConditionHeart Failure With Reduced Ejection Fraction Exercise Training Ferric Carboxymaltose
Intervention/TreatmentInitial FCM Subsequent FCM ...
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.
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.
Initial exercise training program
Initial intravenous iron supplementation (FCM)
Subsequent intravenous iron Supplementation (FCM) after 2 months
Subsequent exercise training program after 2 months
Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program
Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM
Inclusion Criteria: Heart failure with reduced ejection fraction ≤ 40% New York Heart Failure Asssociation class II-III Iron deficiency (ferritin < 100 ng/ml or 100-299 ng/ml, if transferrin saturation < 20%) Exclusion Criteria: Planned cardiovascular interventions (such as bypass surgery or valve interventions) Acute coronary Syndrome Malignant rhythm disturbances Acute or chronic infection Reduced prognosis or exercise capacity by non-cardiac comorbidities Missing informed consent