AuthorisedTherapeutic use (Phase IV)Interventional

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

The CogFer-HF study is investigating how a treatment called intravenous iron (given directly into the vein) affects people living with chronic heart failure who also have low iron levels. Many people with heart failure experience issues like difficulty concentrating, memory problems, and changes in mood, often described as 'brain fog.' This study aims to understand if improving iron levels with this treatment can help improve these thinking skills (cognitive function), reduce feelings of depression and anxiety, and generally improve their quality of life. Participants will receive either the iron treatment or a dummy medicine (placebo) and will be assessed over 24 weeks. It is a Phase IV trial meaning the drug is already widely available, but the researchers are monitoring how it performs under different circumstances. The study is specifically looking at how people's thinking abilities change after 12 and 24 weeks.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Universitaetsmedizin Goettingen

Enrolment target

Start

20 Aug 2024

Heart Failure Iron deficiency (ID)Mild Cognitive Impairment

What is this study about?

You might be interested in the CogFer-HF study if you have chronic heart failure and have been told you also have low iron levels. Many people with heart failure experience an impact on their thinking abilities, sometimes described as 'brain fog,' which can make it hard to concentrate, remember things, or make decisions. They might also feel more anxious or depressed. This study is exploring whether giving a special iron treatment, called ferric derisomaltose, directly into the bloodstream can help to improve these symptoms.

Researchers want to see if boosting your iron levels can make a real difference to these thinking skills, how you feel day-to-day, and your overall quality of life. It's important because while we know iron is vital for many body functions, its specific role in supporting brain health, mood, and well-being in people with heart failure and low iron isn't fully understood. This study aims to provide clearer answers.

Participants in the study will be given either the iron treatment or a matching 'dummy' medicine (placebo). Over several months, the research team will carefully check changes in their thinking abilities using various tests, as well as looking at any changes in mood and how they feel about their daily lives. The insights gained from this study could help improve care for many people living with heart failure in the future.

Key takeaways

The study investigates iron treatment for heart failure patients with low iron.
It focuses on improving thinking skills, mood, and quality of life.
Participants will receive either intravenous iron or a dummy treatment.
Assessments will measure changes in cognitive function, depression, and anxiety.
The study lasts 24 weeks and is open to adults aged 18 and over with heart failure.
This research hopes to improve future care for heart failure patients.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older.

Both men and women can take part. The study is looking for people who have chronic heart failure and also have low iron levels, even if they aren't necessarily anaemic (meaning your red blood cell count isn't necessarily low itself). Participants may also be experiencing mild cognitive impairment, which means they might have some mild difficulties with their thinking or memory.

The research team will carry out a full check to make sure the study is a safe and suitable option for you. This will involve looking at your medical history and current health.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with chronic heart failure?
Have you been told you have low iron levels (with or without anaemia)?
Are you able to attend clinic visits for assessments and treatment?
Do you have any mild difficulties with thinking or memory?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join the CogFer-HF study, you'll be assigned to receive either the intravenous iron treatment (given as an infusion into a vein) or a placebo (a dummy medicine that looks the same but contains no active drug). You won't know which one you're receiving, and neither will the study team, to keep the results fair. Both treatments are given as an infusion into your arm.

You'll have a few visits to the clinic. At the start, there will be a thorough check-up (baseline assessment) where your thinking skills, mood, and quality of life will be assessed using various questionnaires and tests. This initial assessment includes a range of tasks such as Digit Symbol Substitution Test, Trailmaking Test, and memory tests like CERAD-Wordlist. You'll then receive your assigned treatment.

After 12 weeks, you'll have another set of assessments that are similar to the first ones to see if there have been any changes. A final set of assessments will take place at 24 weeks. The study monitors you for a total of 24 weeks (about 6 months) from the time you start.

Potential risks and benefits

Taking part in this study could offer some potential benefits. If you receive the active iron treatment, and it proves effective, you might experience improvements in your thinking abilities, a reduction in symptoms of depression or anxiety, and an overall better quality of life. However, it's also possible you might receive the placebo and experience no direct benefits from the study treatment. As with any medical treatment, there's always a possibility of side effects, though intravenous iron is generally well-tolerated. The research team will explain all known potential risks associated with the iron infusion before you decide to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Germany

Common questions

What is 'brain fog' and how does it relate to heart failure?

Brain fog refers to mild problems with thinking, such as difficulty concentrating, memory issues, or slower processing. Many people with heart failure experience this, and we're trying to see if iron levels play a role.

What is 'intravenous iron'?

Intravenous iron is a treatment where iron is given directly into your bloodstream through a drip in your arm, rather than taking tablets.

Will I know if I'm getting the iron treatment or the placebo?

No, you won't know which you are receiving, and neither will your study doctor. This is to ensure the results of the study are as unbiased as possible.

How long will I be involved in the study?

Your involvement in the study will last for a total of 24 weeks, which is about six months, including your initial assessments and follow-up visits.

What is 'Phase IV' research?

Phase IV means the medicine is already approved and available. This study is looking at how it works in a specific group of patients and for additional benefits, like helping with thinking skills.