Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose

Study Overview
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Brief Summary
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The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment.

Official Title
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Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: ferric carboxymaltose
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic heart failure of New York Heart Association Class II or III, a left ventricular ejection fraction of ≤ 40% for patients in NYHA class II or ≤ 45% for patients in NYHA class III, a hemoglobin level at the screening visit between 9.5-13.5 g/dl, and iron deficiency, which is defined as serum ferritin level < 100µg/l or between 100 and 299 µg/l, when transferring saturation is < 20%. Age ≥18 years Obtained informed consent Stable pharmacological therapy during the last 4 weeks (with the exception of diuretics) Exclusion Criteria: Hemochromatosis, iron overload, defined as TSAT > 45% Known hypersensitivity to Ferinject®. Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range. Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months). History of erythropoietin, i. v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months. Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias. Acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months. Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months. Participation in a CHF training program. Known HIV/AIDS. Inability to fully comprehend and/or perform study procedures in the investigator's opinion. Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy). Pregnancy or lactation. Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study. Anticoagulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ferric carboxymaltose<br>ferric carboxymaltose | Drug: ferric carboxymaltose<br> <br> |
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment | The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure