Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Safety and Tolerability of AC01 in patients with heart failure

Researchers are conducting a study to learn more about a new medication, AC01, designed for individuals living with heart failure. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people. The main goals are to see if AC01 is safe to use and how well people tolerate it, meaning if they can take it without experiencing too many unwanted side effects. The study also aims to figure out the right amount of the medicine to give. This trial is open to adults aged 18 and older, regardless of whether they are male or female, who have been diagnosed with heart failure.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Anacardio AB

Enrolment target

Start

28 Oct 2022

Heart Failure

What is this study about?

You might have heard about 'heart failure' before. It doesn't mean your heart has stopped working entirely, but rather that it's not pumping blood around your body as efficiently as it should. This can lead to symptoms like breathlessness, tiredness, and swollen ankles. Doctors and scientists are always looking for better ways to help people manage this condition and improve their quality of life.

This particular study is focusing on a new medicine, which we'll call AC01. It's a very early-stage trial, sometimes called a Phase I or Phase II study. Think of it like a new recipe – before it can be served to everyone, it needs to be tested in a small group to make sure it's not harmful and tastes good enough. Similarly, before a new medicine can be widely used, it must go through careful testing in clinical trials. The main aim here is to see if AC01 is safe for people to take and if their bodies handle it well. We also want to find the best dose to give.

Taking part in a study like this helps us gather important information about potential new treatments. This knowledge can then be used to develop better medicines that could help many more people with heart failure in the future. It's a crucial step in medical research, and participants play a vital role in advancing our understanding of diseases and potential cures.

Key takeaways

This study is testing a new medicine (AC01) for people with heart failure.
It's an early-stage study focused on safety, how well people tolerate it, and finding the right dose.
Adults aged 18 and over, both men and women, with heart failure, can take part.
Participation involves taking the study medicine and having regular check-ups.
There are potential benefits (new treatment, close monitoring) and risks (unknown side effects).
You can stop participating at any time without affecting your normal healthcare.

Who may be eligible?

To join this study, you would need to be 18 years old or older. There's no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate in this research.

The most important health requirement is that you have a diagnosis of heart failure. The researchers will have specific criteria about your heart failure, which a study doctor would discuss with you in detail. For example, they might look at how well your heart is currently working or what other medications you are taking.

There might be other health reasons that would mean you couldn't take part. These are put in place to ensure your safety and that the study results are as clear as possible. These might include certain other medical conditions or specific medications you are currently taking. The study team will review your full medical history to see if the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with heart failure?
Are you able to attend regular appointments at the study clinic?
Are you comfortable potentially taking a new, untested medicine?
Are you willing to have medical tests like blood samples or heart scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, AC01, as part of the study. The study team would closely monitor your health to see how you respond to the medicine and if you experience any side effects. This would involve regular visits to the study clinic, where you might have check-ups, blood tests, heart scans (like an ECG), and answer questions about how you're feeling.

The total duration of your participation in the study would be explained to you by the research team; typically, early-stage trials involve several visits over a period of weeks or months. You would be given a detailed schedule of all appointments and what to expect at each one. Throughout the study, you would have access to the research team to ask any questions and discuss any concerns.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit of taking part is that you would receive a new medicine, AC01, that is not yet available to everyone. This medicine might help your heart condition. You would also be closely monitored by a medical team, which can be reassuring. For others, the benefit is knowing they are contributing to medical science and helping future patients. However, there are also potential risks; the medicine AC01 is new, so there's a chance you might experience side effects that we don't fully understand yet, or it might not help your condition. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden
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Unverified
Italy
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Unverified
Netherlands

Common questions

What exactly is 'heart failure'?

Heart failure means your heart isn't pumping blood around your body as efficiently as it should. It doesn't mean your heart has stopped working, but it can lead to symptoms like feeling tired or breathless.

What is an 'early-stage' study?

An early-stage study is one of the first times a new medicine is given to people. The main goals are to check if it's safe, how well people tolerate it, and what the best dose might be.

Will I definitely get the new medicine?

Yes, in this study, you would receive the new medicine, AC01. Early-stage trials are usually focused on testing the new treatment directly.

What if I feel unwell during the study?

The study team will monitor you closely. If you feel unwell or have any concerns, you should tell the research staff straight away. They are there to support you.

Will I have to pay to join?

No, you will not have to pay to participate in the study. All study-related care and medication are provided at no cost to you. You may even be reimbursed for travel expenses.