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

Heart Failure With Reduced Ejection Fraction Clinical Trial

— IronEx  

Official title:

A Randomized Trial on Sequential Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03803111
• Other study ID #: BIHKF-7162
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2022
• Source: Herzzentrum Bremen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Exercise Training
• Ferric Carboxymaltose
• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Behavioral:
• Initial exercise training
Initial exercise training program

Drug:
• Initial FCM
Initial intravenous iron supplementation (FCM)
• Subsequent FCM
Subsequent intravenous iron Supplementation (FCM) after 2 months

Behavioral:
• Subsequent exercise training
Subsequent exercise training program after 2 months

Locations

Country	Name	City	State
Germany	Bremer Institut für Herz- und Kreislaufforschung	Bremen

Sponsors (1)

Lead Sponsor	Collaborator
Herzzentrum Bremen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity (Peak VO2)	Peak VO2 is measured by spiroergometry	Change from baseline to 4 months
Secondary	6 Minute walking distance	To further assess exercise capacity	Change from baseline to 4 months
Secondary	New York Heart Association class (class I, II, III, IV with class I = best status, and class IV = worst status)	To assess symptoms	Improvement or deterioration of NYHA class from baseline to 4 months
Secondary	Echocardiographic ejection fraction of left ventricular function (measured in %, the lower the worse)	Systolic and diastolic function, chamber diameters, strain analyses	Improvement or deterioration of ejection fraction from baseline to 4 months
Secondary	Combined endpoint cardiovascular hospitalizations and death	To assess major events	After 2 and 4 months