Cognitive Function, Depression, Anxiety, and Quality of Life in Chronic Heart Failure Patients with Iron Deficiency with and without Anaemia: Effects of Intravenous Iron (Ferric Derisomaltose)

Phase 1

• Conditions: Iron deficiency in patients with chronic heart failure and mild cognitive impairment; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-005383-22-DE
• Lead Sponsor: niversitätsmedizin Göttingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-30
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1.The Patient is willing and able to participate and provides written informed consent;
2.Age = 18 years and < 85;
3.NYHA II-III functional class due to stable symptomatic chronic HF and all of the following;
4.Three months without cardiac hospitalization;
5.Patients in NYHA II: acute care admission or emergency room visit for worsening HF at least once within 24 months prior to start of treatment, but not in the last three months;
6.Appropriate dose of medical therapy for HF (such as ACEi, ARB, ß-blocker, oral diuretics, MRA, ARNI, ivabradine) consistent with prevailing local and international CV guidelines.
7.No dose changes of HF drugs during the last 2 weeks (exception for diuretics);
8.No introduction of a new HF drug class during the last 4 weeks;
9.LVEF = 40 % for both groups of NYHA functional classes; documented within the last 12 months prior to screening;
10.At screening or Visit 1, significantly raised plasma levels of natriuretic peptides (NT-proBNP = 600 pg/ml or BNP = 150 pg/ml) or if they have been hospitalized for HF within the previous 12 months, a NT-proBNP = 400 pg/ml or BNP of at least 100 pg/ml or by patients with atrial fibrillation and HF, a NT-proBNP = 900 pg/ml;
11.Screening ferritin < 100 ng/ml OR ferritin 100-299 ng/ml if TSAT < 20 %;
12.Hb: =10 < 15.0 g/dl
13.Patient must be able to perform the 6 minute walking distance und handgrip strength measurements according to investigator judgment;
14.Mild cognitive impairment according to MoCA Test.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified