Iron deficiency in patients with chronic heart failure and mild cognitive impairment
Conditions
Interventions
Trade Name: MonoFer 100 mg/ml
Product Name: MonoFer 100 mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ferric derisomaltose
CAS Number: 9004-66-04
Other descriptive name: Iron (
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The Patient is willing and able to participate and provides written informed consent; 2. Age = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: 1. Clinical signs and symptoms of infection or C-reactive protein > 20 mg/l; 2. Clinically significant bleeding and subject at an immediate need of transfusion; 3. Active malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia; 4. History of erythropoetin, IV or oral iron therapy, and blood transfusion in previous 4 weeks; 5. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range; 6. Vitamin B12 and/or serum folate deficiency. If deficiency is corrected, patients may be re-screened for inclusion; 7. Haemolytic anaemia and other forms of anaemia not based on ID (e.g. other microcytic anaemia, pernicious anaemia); 8. Known HIV/AIDS; 9. Currently receiving systemic chemotherapy and/or radiotherapy; 10. Renal replacement therapy (previous, current or planned within the next 6 month) or haemodialysis; 11. Severe valvular or left ventricular outflow obstruction disease, obstructive cardiomyopathy; 12. Atrial fibrillation/flutter with a mean ventricular response rate in rest > 100 bpm; 13. Uncontrolled hypertension with blood pressure > 160/100 mmHg; 14. Acute coronary syndrome (STEMI, NSTEMI or unstable angina pectoris), transient ischaemic attack or stroke within the last 3 months; 15. Coronary-artery bypass graft, percutaneous intervention (cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months or planned during the study; 16. Implantation of CRT/ICD within the past 3 months or planned during the study; 17. Subject is pregnant (e.g., positive ß-hCG test) or is breast feeding; 18. Women in childbearing age and not using medically acceptable effective contraception refer to CTFG*; 19. History of acquired iron overload or hemochromatosis (or a first relative with hemochromatosis); 20. Hypersensitivity to the active substance, to FDI or any of its excipients; 21. Earlier hypersensitivity to parental iron preparations or a history of allergic disorders; 22. History of severe asthma, eczema or other atopic allergy; 23. History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis); 24. Concurrent immunosuppressive therapy; 25. Psychosis or dementia (latter assessed by DemTect); 26. Prescribed anti-dementia medication 27. Diagnosed current severe depressive episode (according to ICD-10-GM).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effect of iron repletion with intravenous Ferric Derisomaltose on cognitive function as assessed using a composite score of cognitive function, in patients with stable chronic heart failure (NYHA class II-III, left ventricular ejection fraction = 40 %) and iron deficiency. ;Secondary Objective: Not applicable.;Primary end point(s): Changes in cognitive performance at week 12, compared to baseline, as assessed by a global composite score of cognitive function. This score constitutes the average of z-standardized results of the Digit Symbol Substitution Test, Stroop Color Word Interference Task, Trailmaking-Test, CERAD-Wordlist, Digit Span Backwards Test, and Digit Span Forwards Test.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Changes in cognitive performance at week 24, compared to baseline, as assessed by the global composite score of cognitive function. 2. Changes in single measures of cognitive performance at week 12 and 24 compared to baseline, as assessed by the MoCA Test, Digit Symbol Substitution Test, Stroop Color Word Interference Task, Trailmaking-Test, CERAD-Wordlist, Digit Span Backwards Test, and Digit Span Forwards Test. 3. Reduction in depression from baseline to week 12 and 24, as assessed by HADS. 4. Reduction in general anxiety and heart-focused anxiety from baseline to week 12 and 24, as assessed by HADS and HAF-17 and CAQ. 5. Changes in self-reported quality of life, as assessed by The Kansas City Cardiomyopathy Questionnaire (for HF specific quality of life) and EQ-5D (for general psychological and physical quality of life) from baseline to week 12 and 24. ;Timepoint(s) of evaluation of this end point: Week 12 Week 24 | — |
Countries
Germany
Contacts
Public ContactPrincipal Investigator
Universitätsmedizin Göttingen
Outcome results
None listed