A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Preserved Ejection Fraction
This study is investigating a new medication called Tovinontrine for individuals living with chronic heart failure. This specific type of heart failure means the heart struggles to pump enough blood around the body, even when the pumping chambers seem to be working normally. Researchers want to find out if Tovinontrine is safe to use and if it can help improve the condition. They will compare it to a 'dummy' pill (placebo) to understand its effects better. The main goal is to see if the new medicine can change certain levels in the blood that are linked to heart health after 12 weeks. They'll also look at how patients feel and their quality of life.
At a glance
What is this study about?
This study is about a new medicine called Tovinontrine, which is being tested for people who have a condition called chronic heart failure. Even though the name sounds serious, many people live full lives with this condition, often with the right treatments. In this particular type of heart failure, your heart's main pumping chambers appear to be working well, but the heart still struggles to fill with enough blood, meaning it can't always pump enough blood around your body. This can lead to symptoms like breathlessness and tiredness. The new medicine aims to help the heart work more effectively.
The study is designed to be a careful and fair test. Some participants will receive the new Tovinontrine medicine, while others will receive a 'placebo', which looks exactly like the medicine but contains no active ingredients. This helps researchers understand whether any improvements are truly due to the medicine or other factors. Both the patients and the doctors won't know who is getting which, to keep the results as unbiased as possible.
The main thing researchers will measure is how certain substances in your blood, like NT-proBNP, change over 12 weeks. These substances are markers that give doctors an idea of how much strain your heart is under. They will also look at other blood markers and, very importantly, how you feel. This includes your symptoms, your overall quality of life, and how well you can do daily activities, using special questionnaires. The aim is to find out if Tovinontrine can make a real difference to both what doctors can measure and how patients experience their condition.
Key takeaways
- This study is testing a new medicine for chronic heart failure.
- It aims to see if the medicine is safe and if it helps the heart work better.
- Some patients will get the new medicine, others a dummy pill.
- The study lasts for 12 weeks with regular health checks.
- Your blood and how you feel will be carefully monitored.
Who may be eligible?
To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
More specifically, the study is looking for people who have been diagnosed with chronic heart failure where the heart's main pumping action is still mostly preserved. Your medical team would need to check other specific health details, including your current medications and other health conditions, to ensure the study is right and safe for you.
It's important to remember that even if you meet the age and gender criteria, there are usually detailed medical requirements that a study doctor will need to review to confirm if you can participate.
- Are you 18 years old or older?
- Do you have a diagnosis of chronic heart failure?
- Are you interested in trying a new, experimental treatment?
- Are you comfortable visiting a clinic regularly for assessments and tests for 12 weeks?
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 would be involved for 12 weeks. During this time, you would receive either the new Tovinontrine medicine or a matching dummy pill. You'd take this medicine as an immediate-release tablet as instructed by the study team.
You would have several visits to the clinic for assessments. These visits would involve taking blood and urine samples to check various markers related to your heart health. You would also be asked to complete questionnaires about your symptoms, how you're feeling, and your quality of life. These questionnaires are an important part of understanding how the treatment affects your daily life. The study team would closely monitor your health throughout the 12 weeks.
Potential risks and benefits
Locations (9)
- —Czechia
- —Bulgaria
- —Netherlands
- —Spain
- —Poland
- —Germany
- —Italy
- —Hungary
- —Belgium
Common questions
What is chronic heart failure?
Chronic heart failure means your heart isn't pumping blood as effectively as it should, leading to symptoms like tiredness or breathlessness.
What is Tovinontrine?
Tovinontrine is a new medicine being tested to see if it can help improve heart function in people with a specific type of chronic heart failure.
What is a 'dummy pill'?
A 'dummy pill' (or placebo) looks exactly like the study medicine but contains no active ingredients. It's used for comparison.
How long does the study last?
The active part of the study where you take medicine and have assessments lasts for 12 weeks.
Will I know if I'm getting the real medicine?
No, neither you nor your doctor will know if you're getting the active medicine or the dummy pill until after the study has finished. This helps ensure fair results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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