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

Herzzentrum Bremen

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Heart Failure With Reduced Ejection Fraction Exercise Training Ferric Carboxymaltose

Interventions

Initial exercise trainingBEHAVIORAL

Initial exercise training program

Initial FCMDRUG

Initial intravenous iron supplementation (FCM)

Subsequent FCMDRUG

Subsequent intravenous iron Supplementation (FCM) after 2 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bremer Institut für Herz- und Kreislaufforschung

Bremen, Germany

Outcomes

Primary Outcomes

Exercise capacity (Peak VO2)

Peak VO2 is measured by spiroergometry

Time frame: Change from baseline to 4 months

Secondary Outcomes

6 Minute walking distance

To further assess exercise capacity

Time frame: Change from baseline to 4 months

New York Heart Association class (class I, II, III, IV with class I = best status, and class IV = worst status)

To assess symptoms

Time frame: Improvement or deterioration of NYHA class from baseline to 4 months

Echocardiographic ejection fraction of left ventricular function (measured in %, the lower the worse)

Systolic and diastolic function, chamber diameters, strain analyses

Time frame: Improvement or deterioration of ejection fraction from baseline to 4 months

Combined endpoint cardiovascular hospitalizations and death

To assess major events

Time frame: After 2 and 4 months

Data from ClinicalTrials.gov

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