A Phase IIb Two-cohort, Randomised, Placebo-controlled, Double-blind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients with Chronic Heart Failure
This research is looking into a new medication called AZD5462 for individuals who have stable, long-term heart failure. The main goal is to find out if this medicine can improve how effectively the heart pumps blood. Researchers will use ultrasound scans of the heart at the beginning and again at 25 weeks to measure any changes. Some people will receive AZD5462, while others will get a placebo (a dummy pill that looks the same but contains no medicine). This helps scientists compare the effects fairly. The study is also checking for changes in health and heart-related markers in the blood. This type of study is an important step in carefully testing new treatments to see if they are safe and effective.
At a glance
What is this study about?
This study is a research project designed to test a new medication called AZD5462 for people living with chronic heart failure. 'Chronic' means it's a long-term condition where the heart doesn't pump blood as well as it should. The aim is to see if AZD5462 can improve the heart's pumping ability, which is a crucial part of managing heart failure and can help people feel better and live more comfortably.
To understand if the medicine works, researchers will compare its effects against a 'placebo.' A placebo is a dummy pill that looks exactly like the real medicine but contains no active ingredients. This is a common and important part of medical research, as it helps scientists tell if any changes seen are truly due to the new medicine or if they might have happened anyway. Neither you nor your doctor will know if you are receiving the active medicine or the placebo during the study, so everyone's experience is treated fairly.
The study will involve regular check-ups, including ultrasound scans of the heart (called echocardiograms), to measure how well your heart is pumping at the start of the study and throughout. They will specifically look for changes after 25 weeks. They'll also monitor your general health, how you feel day-to-day, and take blood samples to check for specific markers that tell us about heart health. This careful approach helps researchers gather detailed information to determine if AZD5462 is a safe and potentially effective treatment option in the future.
Key takeaways
- The study tests a new heart failure medicine called AZD5462.
- It aims to see if the medicine improves how well the heart pumps.
- Participation involves regular visits, heart scans, and blood tests over 25 weeks.
- You may receive the actual medicine or a dummy pill (placebo).
- It's for people with stable, long-term heart failure, aged 18 and over.
Who may be eligible?
To be considered for this study, you must be 18 years old or older. There is no upper age limit, meaning older adults can also take part if they meet the other criteria. The study welcomes both men and women.
An important condition for this study is that you must have stable chronic heart failure. This means your heart failure should be well-managed and not experiencing any sudden worsening or unstable symptoms at the time of joining the study. The study looks for people whose condition is steady. Your heart doctor will be able to tell you if your heart failure is considered stable enough to participate.
Beyond these general points, there will be other specific health requirements and exclusions that only your doctor can fully explain. These might include other medical conditions you have, medicines you are currently taking, or specific results from medical tests. These detailed criteria are put in place to ensure the safety of everyone taking part and the accuracy of the study results.
- Are you 18 years old or older?
- Do you have chronic (long-term) heart failure?
- Is your heart failure considered stable by your doctor?
- Are you able to attend appointments regularly for about 6 months?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be assigned randomly to either receive the new medicine, AZD5462, or a placebo (a dummy pill). You will need to take tablets regularly throughout the study. You'll have several visits to the study clinic, particularly at the beginning, and then at specific times over 25 weeks. These visits will involve various assessments, including physical examinations, taking blood samples, and having ultrasound scans of your heart (echocardiograms) to measure how well it's working. You will also be asked questions about how you are feeling and your overall health. These visits typically occur at weeks 3, 5, 13, and 25. The total duration of your active participation in the study, from your first visit to your last, will be about 25 weeks (roughly six months). There may also be follow-up phone calls or check-ups after this period.
Potential risks and benefits
Locations (7)
- —Bulgaria
- —Czechia
- —Poland
- —Denmark
- —Netherlands
- —Hungary
- —Slovakia
Common questions
What is chronic heart failure?
Chronic heart failure is a long-term condition where your heart can't pump enough blood around your body to meet its needs.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks like the real medicine but doesn't contain any active ingredients. It helps researchers fairly compare the new medicine's effects.
What's an echocardiogram?
An echocardiogram is a type of ultrasound scan that uses sound waves to create moving pictures of your heart, showing how well it's pumping.
Will I know if I'm getting the real medicine?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know if you're receiving AZD5462 or the placebo until after the study ends.
How long will the study last for me?
If you join, your participation will last about 25 weeks, which is roughly six months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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