Randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of 2 dose levels of the oral ghrelin receptor agonist AC01 over 12 weeks in patients with chronic advanced heart failure with reduced ejection fraction (HFrEF)
This clinical trial is looking at a new medicine called AC01 for adults living with long-term, advanced heart failure. In this condition, the heart muscle becomes weak and struggles to pump blood around the body as well as it should. The study aims to find out if taking AC01 tablets every day for 12 weeks can improve how well the heart works, and whether it is safe. Researchers will compare two different doses of AC01 against a placebo, which is an inactive dummy pill that looks identical. Doctors will use ultrasound scans of the heart, known as echocardiograms, to see if the medicine helps the heart pump more blood with each beat. About one in three participants will receive the dummy pill so doctors can clearly see if any improvements are truly caused by the new medicine.
At a glance
What is this study about?
Heart failure is a long-term condition where the heart cannot pump blood around the body as strongly as it normally would. When doctors speak about 'reduced ejection fraction', they mean the main pumping chamber of the heart has become weakened and pushes out less blood with each heartbeat. This can leave people feeling very tired, short of breath, and less able to carry out daily activities. While existing treatments help manage symptoms, doctors are constantly searching for new ways to support and strengthen the heart muscle.
This trial is investigating a new oral medicine called AC01. It is designed to act on natural pathways in the body that may help support heart function and energy. Researchers want to see whether taking AC01 daily can safely help the heart pump more blood and reduce strain on its chambers over a 12-week period.
To find out if AC01 works, the study uses special ultrasound scans of the heart called echocardiograms. These scans take detailed measurements of the heart's size and pumping strength before and after treatment. If the study shows positive results, it could help guide the development of a brand-new type of treatment for people living with advanced heart failure in the future.
Key takeaways
- Tests a new daily tablet (AC01) designed to support a weakened heart.
- Aimed at adults aged 18 and over with long-term, advanced heart failure.
- Lasts for 12 weeks and involves regular clinic visits and heart ultrasound scans.
- Compares two different doses of the medicine against an inactive dummy pill.
- Taking part is completely voluntary and you can leave at any time.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with chronic, advanced heart failure with reduced ejection fraction. This means your heart has been struggling to pump blood efficiently for some time, and you likely experience noticeable symptoms despite receiving standard medical care.
Both men and women may be able to join. However, because this trial tests a specific new medicine, the research team will need to check your general health, your current medications, and the exact pumping strength of your heart to ensure it is completely safe for you to take part.
People with certain other medical conditions, severe kidney problems, or those who are pregnant or breastfeeding may not be able to join. The study doctors will carry out health checks and scans to confirm whether this trial is a good match 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.
- I am aged 18 or older.
- I have been diagnosed with long-term (chronic) heart failure.
- My doctor has told me my heart has a reduced pumping strength (reduced ejection fraction).
- I am able to attend regular hospital appointments over a 12-week period.
- I am happy to take a daily tablet that may be the study medicine or a dummy pill.
What does participation involve?
If you take part, your participation will last for at least 12 weeks. You will be placed by chance into one of three groups: one group takes a lower dose of AC01, one takes a higher dose, and one takes a placebo (a dummy pill containing no active medicine). Neither you nor your doctor will know which group you are in, which ensures the results are completely fair.
You will take your assigned study tablets by mouth every day at home. During the 12 weeks, you will visit the hospital clinic several times so the research team can keep a close eye on your health. These visits will include regular physical checks, blood tests, and ultrasound scans of your heart (echocardiograms) to measure how well it is pumping.
The trial team will also monitor your symptoms and ask how you are feeling. Once the 12 weeks of treatment finish, there may be a follow-up visit or telephone call to make sure you remain well after stopping the study medicine.
Potential risks and benefits
Locations (10)
- —UnverifiedCzechia
- —UnverifiedSlovakia
- —UnverifiedSpain
- —UnverifiedBulgaria
- —UnverifiedNetherlands
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedSweden
- —UnverifiedHungary
Common questions
What is a placebo?
A placebo is a dummy pill that looks and tastes just like the study medicine but contains no active ingredients. It helps doctors see if changes are truly caused by the new drug.
Will I have to stop taking my usual heart medications?
No, you will usually continue taking your standard prescribed heart medications. The study team will review all your tablets to ensure they are safe to take alongside the trial drug.
What is an echocardiogram?
An echocardiogram is a painless ultrasound scan that uses sound waves to create moving pictures of your heart, showing how well its muscles and valves are working.
Can I leave the study early if I change my mind?
Yes. Taking part is completely voluntary, and you can withdraw at any point without giving a reason and without any impact on your everyday medical care.
Do I have to pay to take part?
No, all study medicines, tests, and scans are provided free of charge. Many trials also help cover reasonable travel expenses for hospital visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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