Exercise Training, Ferric Carboxymaltose, Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Heart Failure with Reduced Ejection Fraction, Exercise Training Program, Iron Deficiency
Brief 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.
Detailed 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.
Interventions
BEHAVIORALInitial exercise training
Initial exercise training program
DRUGInitial FCM
Initial intravenous iron supplementation (FCM)
DRUGSubsequent FCM
Subsequent intravenous iron Supplementation (FCM) after 2 months
BEHAVIORALSubsequent exercise training
Subsequent exercise training program after 2 months
Sponsors
Herzzentrum Bremen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity (Peak VO2) | Change from baseline to 4 months | Peak VO2 is measured by spiroergometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute walking distance | Change from baseline to 4 months | To further assess exercise capacity |
| New York Heart Association class (class I, II, III, IV with class I = best status, and class IV = worst status) | Improvement or deterioration of NYHA class from baseline to 4 months | To assess symptoms |
| Echocardiographic ejection fraction of left ventricular function (measured in %, the lower the worse) | Improvement or deterioration of ejection fraction from baseline to 4 months | Systolic and diastolic function, chamber diameters, strain analyses |
| Combined endpoint cardiovascular hospitalizations and death | After 2 and 4 months | To assess major events |
Countries
Germany
Outcome results
None listed