Study on the Effects of Ferric Derisomaltose on Cognitive Function in Heart Failure Patients with Iron Deficiency

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients with Chronic Heart Failure who also have Iron Deficiency, with or without Anaemia. The treatment being tested is an intravenous iron supplement called Ferric Derisomaltose. The purpose of the study is to evaluate how this treatment affects cognitive function, which includes memory and thinking skills, in these patients.

Participants in the study will receive the treatment through an infusion, which is a way of delivering medication directly into the bloodstream. The study will last for 12 weeks, during which time the effects of the treatment on cognitive function will be assessed. This will be done using a series of tests that measure different aspects of cognitive performance. The study will also look at changes in depression, anxiety, and quality of life over the course of the treatment.

In addition to the main focus on cognitive function, the study will also monitor changes in depression and anxiety levels, as well as overall quality of life. These aspects will be evaluated at the start of the study and again at 12 and 24 weeks to see if there are any improvements. The study aims to provide valuable information on how treating iron deficiency in patients with chronic heart failure can impact their mental and emotional well-being.

1 joining the study

Upon joining the study, the patient provides written informed consent, confirming willingness and ability to participate.

Initial assessments are conducted to ensure eligibility, including blood tests to measure specific markers and a cognitive test to evaluate mild cognitive impairment.

2 baseline assessments

Baseline assessments are performed to establish initial health status. These include cognitive tests, depression and anxiety evaluations, and quality of life questionnaires.

Physical tests such as a 6-minute walking test and handgrip strength measurements are also conducted.

3 treatment administration

The patient receives intravenous ferric derisomaltose as part of the treatment. This is administered as an infusion, which is a method of delivering medication directly into the bloodstream.

The treatment aims to replenish iron levels in patients with iron deficiency and chronic heart failure.

4 follow-up assessments at week 12

At week 12, follow-up assessments are conducted to evaluate changes in cognitive performance, depression, anxiety, and quality of life.

These assessments include a series of cognitive tests and questionnaires similar to those conducted at baseline.

5 follow-up assessments at week 24

At week 24, further assessments are performed to monitor ongoing changes in cognitive function, mood, and quality of life.

The same tests and questionnaires are used to compare results with baseline and week 12 assessments.

6 completion of study participation

Upon completion of the study, the patient receives a final evaluation to summarize the effects of the treatment.

The study aims to conclude by the end of 2025, with all data collected and analyzed to understand the impact of the treatment on cognitive function and overall well-being.

Who Can Join the Study?

The patient is willing and able to participate and provides written informed consent.
At screening or Visit 1, the patient has significantly raised plasma levels of natriuretic peptides (NT-proBNP ≥ 600 pg/ml or BNP ≥ 150 pg/ml). If they have been hospitalized for heart failure (HF) within the previous 12 months, NT-proBNP should be ≥ 400 pg/ml or BNP at least 100 pg/ml. For patients with atrial fibrillation and HF, NT-proBNP should be ≥ 900 pg/ml.
Screening ferritin levels are less than 100 ng/ml, or ferritin is between 100-299 ng/ml if TSAT (transferrin saturation) is less than 20%.
Hemoglobin (Hb) levels should be between 10 and 15.0 g/dl.
The patient must be able to perform the 6-minute walking test and handgrip strength measurements according to the investigator’s judgment.
The patient has mild cognitive impairment according to the MoCA Test (MoCA Score of 19-25, including), with a subjective memory concern reported by the patient, informant, or clinician, and preserved activities of daily living.
The patient is aged 18 years or older and younger than 85 years.
The patient is in NYHA II-III functional class due to stable symptomatic chronic HF and meets all of the following:

Has not been hospitalized for cardiac issues in the last three months.
For patients in NYHA II: Has had at least one acute care admission or emergency room visit for worsening HF within 24 months prior to the start of treatment, but not in the last three months.
Is on an appropriate dose of medical therapy for HF, such as ACE inhibitors, ARBs, beta-blockers, oral diuretics, MRAs, ARNIs, or ivabradine, consistent with local and international cardiovascular guidelines.
Has not had any dose changes of HF drugs during the last two weeks, except for diuretics.
Has not introduced a new HF drug class during the last four weeks.
Has a left ventricular ejection fraction (LVEF) of 40% or less for both groups of NYHA functional classes, documented within the last 12 months prior to screening.

Who Cannot Join the Study?

Patients with severe heart failure, which means their heart is not pumping blood as well as it should, cannot participate.
Patients with severe cognitive impairment, which means having significant problems with memory or thinking, are excluded.
Patients who do not have iron deficiency, which means they have enough iron in their body, cannot join the study.
Patients who are not stable, meaning their health condition is not steady or under control, are excluded.
Patients who are not in the age range specified for the study cannot participate.
Patients who are part of a vulnerable population, meaning they might be at risk of harm or exploitation, are not allowed to join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsmedizin Goettingen	Goettingen	Germany

Other Sites

Site Name	City	Country	Status
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie	Homburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	04.06.2024

Trial locations

Investigated drugs:

Ferric Derisomaltose is an intravenous iron therapy used in this study. It is designed to replenish iron levels in patients with chronic heart failure who have iron deficiency, with or without anemia. The goal of using this medication is to improve cognitive function, as well as potentially alleviate symptoms of depression and anxiety, and enhance the overall quality of life for these patients.

Investigated diseases:

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively, leading to insufficient blood flow to meet the body’s needs. It can result from various underlying heart conditions, such as coronary artery disease or high blood pressure. Over time, the heart’s ability to pump may weaken, causing symptoms like shortness of breath, fatigue, and fluid retention. The condition can progress gradually, with symptoms worsening as the heart’s function declines. It is often classified based on the severity of symptoms and the heart’s ejection fraction, which measures how well the heart pumps with each beat.

Mild Cognitive Impairment – Mild cognitive impairment (MCI) is a condition characterized by noticeable changes in cognitive abilities, such as memory and thinking skills, that are greater than expected for a person’s age but do not interfere significantly with daily life. Individuals with MCI may experience forgetfulness, difficulty concentrating, or challenges in decision-making. While MCI can remain stable for some, it may progress to more severe cognitive disorders, such as dementia, in others. The progression of symptoms varies among individuals, and some may even experience improvement over time. MCI is often identified through cognitive assessments and monitoring of changes in cognitive function.

Iron Deficiency – Iron deficiency occurs when the body lacks sufficient iron to produce adequate levels of hemoglobin, the protein in red blood cells responsible for carrying oxygen. This deficiency can lead to symptoms such as fatigue, weakness, and pale skin. It often develops gradually and can result from inadequate dietary intake, increased iron needs, or blood loss. As iron levels continue to drop, the body may struggle to maintain normal physiological functions, potentially leading to anemia. The progression of iron deficiency can vary, with some individuals experiencing mild symptoms while others may develop more pronounced effects.

Trial ID:

2024-515046-17-00

Protocol code:

Kognition

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Ferric Derisomaltose on Cognitive Function in Heart Failure Patients with Iron Deficiency

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?