A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction
This research study is investigating a new oral medication called levosimendan for adults who have pulmonary hypertension and a specific type of heart failure (where the heart's main pumping chamber still works well). The main goal is to find out if this medicine can improve how far people can walk in six minutes and if it's safe to use. Researchers also want to see if it helps with breathlessness, fatigue, and reduces the chance of needing hospital care. Participants will either receive the active medicine or a dummy pill (placebo) to ensure a fair comparison. The study will last for about six months.
At a glance
What is this study about?
This study is looking into a new medicine called levosimendan for people who have both pulmonary hypertension and a type of heart failure. Pulmonary hypertension means you have high blood pressure in the arteries leading from your heart to your lungs. Heart failure in this study refers to a specific kind where your heart still pumps blood well, but it might not relax properly to fill with enough blood. Both conditions can make you feel very tired and breathless, making everyday activities difficult.
The main purpose of this study is to see if levosimendan can help people with these conditions feel better and improve their ability to be active. Researchers will measure this by seeing if people can walk further in six minutes after taking the medicine for a period of time. They will also carefully check for any side effects to make sure the medicine is safe. By comparing the new medicine to a dummy pill (placebo), the doctors can tell if any improvements are truly due to the medicine itself and not just other factors.
Understanding if levosimendan can safely improve the lives of people with these challenging conditions is really important. If successful, it could offer a new treatment option to help people manage their symptoms and improve their overall quality of life. This kind of research helps doctors find better ways to care for patients.
Key takeaways
- Tests a new oral medicine, levosimendan, for lung high blood pressure and heart failure.
- Aims to improve walking distance and overall well-being.
- Compares the medicine to a dummy pill (placebo) over about six months.
- Requires regular clinic visits for checks, tests, and monitoring.
- Focuses on both the effectiveness and safety of the new treatment.
Who may be eligible?
To be part of this study, you need to be an adult, at least 18 years old. Both men and women can take part.
You would also need to have been diagnosed with pulmonary hypertension *and* a specific type of heart failure where the main pumping chamber of your heart (the left ventricle) still pumps blood effectively. Your doctor would carry out tests to confirm these diagnoses and to make sure your overall health meets other specific requirements for the study.
The study team will review all your medical information carefully to decide if this particular new medicine might be suitable 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?
- Do you have a diagnosis of pulmonary hypertension?
- Do you have a diagnosis of heart failure where your heart still pumps well?
- Are you comfortable taking an oral medication?
- Are you able to attend regular clinic appointments for about six months?
What does participation involve?
If you decide to take part in this study, you would receive either the active study medicine, levosimendan, or a matching dummy pill (placebo) to take by mouth. Neither you nor your study doctor would know which one you are taking – this is to make sure the results are fair. The study is planned to last for about 26 weeks, which is roughly six months.
Throughout the study, you would have several visits to the clinic. At these visits, doctors and nurses would perform various checks. This includes physical examinations, taking your vital signs (like blood pressure and heart rate), taking blood samples for lab tests, and performing heart scans (ECGs) to monitor your heart's electrical activity. You would also have regular tests, including a 6-minute walking test, to see if the treatment is making a difference.
Your safety will be monitored very closely. The study team will ask about any side effects you might experience and keep track of your overall health. There will also be a system in place to monitor your heart rate and rhythm regularly.
Potential risks and benefits
Locations (9)
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- —UnverifiedItaly
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- —UnverifiedPoland
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- —UnverifiedSpain
Common questions
What is pulmonary hypertension?
It's a condition where the blood pressure in the arteries going to your lungs is too high, making your heart work harder.
What is heart failure with preserved ejection fraction?
It means your heart's main pumping chamber still squeezes well, but it might not relax efficiently to fill with enough blood.
What is a 'placebo'?
A placebo is a dummy pill that looks just like the study medicine but contains no active drug. It helps compare the real medicine's effects.
How long will the study last?
The main part of the study will last for about 26 weeks, which is roughly six months.
What is a 6-minute walking test?
It's a simple test where you walk as far as you can in six minutes, allowing doctors to measure your exercise ability.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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