Trial | NCT03803111  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
Study Started
Jan 01
2021
Primary Completion
Mar 15
2022
Study Completion
Mar 15
2022
Last Update
Mar 16
2022

Behavioral Initial exercise training

Initial exercise training program

Drug Initial FCM

Initial intravenous iron supplementation (FCM)

Drug Subsequent FCM

Subsequent intravenous iron Supplementation (FCM) after 2 months

Behavioral Subsequent exercise training

Subsequent exercise training program after 2 months

Initial FCM Experimental

Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program

Initial exercise Experimental

Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM

Criteria 

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
No Results Posted