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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03803111
Other study ID # BIHKF-7162
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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