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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) CogFer-HF Study
EU CTIS ID: 2024-515046-17-00
What this study is testing
The primary objective of the study is to evaluate the effect of iron repletion with intravenous Ferric Derisomaltose (IV FDI) after 12 weeks on cognitive function as assessed using a composite score of cognitive function, in patients with stable chronic HF (NYHA class II-III, LVEF ≤ 40 %) and ID.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The Patient is willing and able to participate and provides written informed consent
- 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
- Screening ferritin < 100 ng/ml or ferritin 100-299 ng/ml if TSAT < 20 %
- Hb: ≥10 < 15.0 g/dl
- Patient must be able to perform the 6-minute walking test und handgrip strength measurements according to investigator judgment
- Mild cognitive impairment according to MoCA Test (MoCa Score of 19- 25, including), subjective memory concern reported by patient, informant or clinician, preserved activities of daily living
You likely can't join if
- Clinical signs and symptoms of infection or C-reactive protein > 20 mg/l
- Renal replacement therapy (previous, current or planned within the next 6 months) or haemodialysis
- Severe valvular or left ventricular outflow obstruction disease, obstructive cardiomyopathy
- Atrial fibrillation/flutter with a mean ventricular response rate in rest > 100 bpm
- Uncontrolled hypertension with blood pressure > 160/100 mmHg
- Acute coronary syndrome (STEMI, NSTEMI or unstable angina pectoris), transient ischaemic attack or stroke within the last 3 months
See the full eligibility criteria
Who can join
- The Patient is willing and able to participate and provides written informed consent
- 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
- Screening ferritin < 100 ng/ml or ferritin 100-299 ng/ml if TSAT < 20 %
- Hb: ≥10 < 15.0 g/dl
- Patient must be able to perform the 6-minute walking test und handgrip strength measurements according to investigator judgment
- Mild cognitive impairment according to MoCA Test (MoCa Score of 19- 25, including), subjective memory concern reported by patient, informant or clinician, preserved activities of daily living
- Age ≥ 18 years and < 85
- NYHA II-III functional class due to stable symptomatic chronic HF and all of the following
- Three months without cardiac hospitalization
- 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
- 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
- No dose changes of HF drugs during the last 2 weeks (exception for diuretics)
- No introduction of a new HF drug class during the last 4 weeks
- LVEF ≤ 40 % for both groups of NYHA functional classes; documented within the last 12 months prior to screening
What rules you out
- Clinical signs and symptoms of infection or C-reactive protein > 20 mg/l
- Renal replacement therapy (previous, current or planned within the next 6 months) or haemodialysis
- Severe valvular or left ventricular outflow obstruction disease, obstructive cardiomyopathy
- Atrial fibrillation/flutter with a mean ventricular response rate in rest > 100 bpm
- Uncontrolled hypertension with blood pressure > 160/100 mmHg
- Acute coronary syndrome (STEMI, NSTEMI or unstable angina pectoris), transient ischaemic attack or stroke within the last 3 months
- 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
- Implantation of CRT/ICD within the past 3 months or planned during the study
- Subject is pregnant (e.g., positive ß-hCG test) or is breast feeding
- Women of childbearing potential (WOCBP) and not using highly effective contraception refer to CTFG
- History of acquired iron overload or hemochromatosis (or a first relative with hemochromatosis)
- Clinically significant bleeding and subject at an immediate need of transfusion
- Hypersensitivity to the active substance, to FDI or any of its excipients
- Earlier hypersensitivity to parental iron preparations or a history of allergic disorders
- History of severe asthma, eczema or other atopic allergy
- History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
- Concurrent immunosuppressive therapy
- Diagnosis of Psychosis or dementia
- MoCa < 19
- Prescribed anti-dementia medication
- Known history of alcohol or drug abuse within 5 years prior
- Medications that may negatively affect cognitive function (eg, sedatives, antipsychotics, anti-epileptics) are not allowed unless subjects are on a stable dose at the time of screening and are expected to continue on a stable dose for the duration of the trial.
- Active malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia
- Diagnosed current severe depressive episode (according to ICD-10-GM)
- History of erythropoetin, IV or oral iron therapy, and blood transfusion in previous 4 weeks
- Chronic liver disease and/or screening alanine transaminase (ALAT) or aspartate transaminase (ASAT) above three times the upper limit of the normal range
- Vitamin B12 and/or serum folate deficiency. If deficiency is corrected, patients may be re-screened for inclusion
- Haemolytic anaemia and other forms of anaemia not based on ID (e.g. other microcytic anaemia, pernicious anaemia)
- Medical treatment for known HIV/AIDS
- Currently receiving systemic chemotherapy and/or radiotherapy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.