Heart Failure With Reduced Ejection Fraction Clinical Trial
— IronExOfficial title:
A Randomized Trial on Sequential Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
Verified date | March 2022 |
Source | Herzzentrum Bremen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
Germany | Bremer Institut für Herz- und Kreislaufforschung | Bremen |
Lead Sponsor | Collaborator |
---|---|
Herzzentrum Bremen |
Germany,
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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