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

Not Applicable

Withdrawn

• Conditions: Heart Failure With Reduced Ejection Fraction; Exercise Training; Ferric Carboxymaltose
• Interventions: Behavioral: Initial exercise training; Drug: Initial FCM; Behavioral: Subsequent exercise training; Drug: Subsequent FCM

• Registration Number: NCT03803111
• Lead Sponsor: Herzzentrum Bremen

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.

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Study Start: 2021-01-01
• Status Verified: 2022-03
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Initial FCM	Subsequent exercise training	Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program
Initial exercise	Subsequent FCM	Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM
Initial exercise	Initial exercise training	Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM
Initial FCM	Initial FCM	Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program

Primary Outcome Measures

Name	Time	Method
Exercise capacity (Peak VO2)	Change from baseline to 4 months	Peak VO2 is measured by spiroergometry

Secondary Outcome Measures

Name	Time	Method
6 Minute walking distance	Change from baseline to 4 months	To further assess exercise capacity
Combined endpoint cardiovascular hospitalizations and death	After 2 and 4 months	To assess major events
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

Trial Locations

Locations (1)

Bremer Institut für Herz- und Kreislaufforschung; 🇩🇪 Bremen, Germany