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

Herzzentrum Bremen

Status: Withdrawn

Conditions: Ferric Carboxymaltose; Exercise Training; Heart Failure With Reduced Ejection Fraction

Treatments: Behavioral: Initial exercise training; Drug: Subsequent FCM; Drug: Initial FCM; Behavioral: Subsequent exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT03803111

BIHKF-7162

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Initial FCM

Experimental group

Description:

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

Treatment:

Drug: Initial FCM

Behavioral: Subsequent exercise training

Initial exercise

Experimental group

Description:

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

Treatment:

Behavioral: Initial exercise training

Drug: Subsequent FCM