Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients with Functional Iron Deficiency

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 21 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are between the ages of 21 and 75 years old
    2. Subjects with Symptomatic NYHA Class II-III heart failure >3 months
    3. Subjects with Guideline-recommended heart failure treatment for > 3 months
    4. Subjects with Hemoglobin >10 g/dl for men and >9 g/dl for women
    5. Subjects who have functional iron deficiency
    6. Subjects with left ventricular ejection fraction <40%, or left ventricular ejection fraction =40% with left atrial enlargement and/or left ventricular hypertrophy as determined by echocardiogram within last 24 months.
    7. Subjects who are able and willing to provide written informed consent

You may not be eligible for this study if the following are true:

    1. Subjects with presence of implantable defibrillator, permanent pacemaker, other metal implant not compatible with 3TMRS/MRI, or other contraindication to 3T MRS/MRI procedures
    2. Subjects with heart failure due to infiltrative cardiomyopathy, restrictive cardiomyopathy, or hypertrophic cardiomyopathy
    3. Subjects with weight <50 kg or >120 kg
    4. Subjects with height < 5 feet 4 inches (1.63 m)
    5. Subjects with coronary or cerebral atherothrombotic events in the past 6 months
    6. Subjects with Hospitalization of emergency room visit for heart failure within past 3 months
    7. Subjects who had ICD shock in last 3 months
    8. Subjects with known peripheral artery disease or ankle-brachial index <0.9 at screening visit
    9. Subjects who exercise primarily limited by angina, lung disease or neuromuscular disease
    10. Subjects with systolic blood pressure <100 or >160 mmHg
    11. Subjects with heart rate <50 or >110 min-1
    12. Subjects with estimated glomerular filtration rate <30 ml/min
    13. Subjects with liver function tests >3 times upper limit of normal
    14. Subjects with serum phosphate below normal limit
    15. Subjects who are pregnant or breast-feeding women
    16. Female subjects of child-bearing potential unwilling to use recommended contraception methods during the study
    17. Subjects who have treatment with intravenous iron in past year
    18. Subjects who have treatment with erythropoiesis stimulating agents in the past year
    19. Subjects with known intolerance of intravenous iron
    20. Subjects with history of anaphylaxis
    21. Subject who participated in another clinical trial within last 30 days.

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