LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
This UK-based study, called LEVEL-2, is investigating a new drug called TNX-103 (also known as levosimendan) for individuals who have both high blood pressure in the lungs (pulmonary hypertension) and a specific type of heart failure where the heart’s pumping action appears normal but struggles to fill with blood (Heart Failure with preserved Ejection Fraction, or HFpEF). The main goal is to see if TNX-103 can help people walk further in a 6-minute test, which is a way to measure how well they can exercise, compared to a placebo (a dummy pill). The study also looks at the drug's safety. It's a Phase 3 trial, meaning it's in the later stages of testing before potential approval, and aims to enrol around 540 participants.
At a glance
What is this study about?
This study, called LEVEL-2, is investigating a new oral medication, TNX-103 (also known as levosimendan), for people in the UK who have a specific and challenging condition. This condition combines high blood pressure in the lungs (called pulmonary hypertension, or PH) with a type of heart failure where the heart muscle seems to pump blood normally, but it's stiff and doesn't fill properly between beats (called Heart Failure with preserved Ejection Fraction, or HFpEF). People with this combination often find it difficult to exercise and experience shortness of breath, tiredness, and swelling.
The main purpose of this research is to find out if TNX-103 can help improve how far people with PH-HFpEF can walk in a 6-minute test. This test is a common way to measure how well someone can exercise and how their condition affects their daily life. The study will compare TNX-103 to a placebo, which is an inactive dummy pill. This helps researchers understand if any improvements are genuinely due to the study drug or something else.
By comparing the new drug to a placebo, the researchers hope to understand if TNX-103 can make a real difference in the lives of people with PH-HFpEF, making it easier for them to be active and potentially improving their overall well-being. The study will also carefully check for any side effects to make sure the drug is safe to use.
Key takeaways
- Investigates a new oral drug, TNX-103, for PH-HFpEF.
- Compares TNX-103 to a placebo (dummy pill).
- Aims to improve exercise ability, measured by a 6-Minute Walk Test.
- Participation involves regular health checks and drug intake.
- Open to adults aged 18-85 with a specific diagnosis.
- Opportunity for extended treatment in an 'open label' phase.
Who may be eligible?
To join this study, you need to be an adult between 18 and 85 years old. You should have symptoms like shortness of breath or tiredness that fit into certain categories (NYHA Class II, III, or active Class IV), indicating how much your heart condition affects your daily life. It's essential that doctors have diagnosed you with a specific type of high blood pressure in the lungs combined with heart failure as described above, confirmed by detailed heart tests.
There are also some reasons why you might not be able to join. For example, if your high blood pressure in the lungs is from a different cause, or if you have certain other heart conditions like severe valve problems, very stiff heart muscle (restrictive cardiomyopathy), or a history of allergic reactions to similar medicines. Also, if you’ve had major surgery recently, or have serious lung disease, or have had a heart or lung transplant, you might not be eligible. This is to ensure the study is safe for participants and that results are clear.
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 between 18 and 85 years old?
- Have you been diagnosed with high blood pressure in your lungs AND a type of heart failure where your heart struggles to fill?
- Do you experience symptoms like shortness of breath or tiredness that affect your daily life?
- Have specialist doctors confirmed your exact heart and lung condition with detailed tests?
- Do you NOT have certain other serious heart or lung conditions (like severe valve problems or recent major surgery)?
- Are you willing to take an oral medication and attend regular study appointments?
What does participation involve?
If you join this study, you’ll be randomly assigned to either receive the study drug TNX-103 or a placebo (a dummy pill). There’s a two-in-three chance you’ll get the active drug. Both TNX-103 and the placebo are taken by mouth. The study involves regular visits where you’ll have various health checks, including physical exams, blood tests, and heart assessments. The main way they'll measure the drug's effect is by seeing how far you can walk in 6 minutes at different points during the study. After the initial part of the study, if you qualify, you might have the option to continue taking the study drug for an extended period of about 1 year (52 weeks) in an 'open label' phase, meaning everyone will receive the active drug. The total duration of your participation will depend on whether you join this extension.
Potential risks and benefits
Locations (92)
- Tenax Investigational SiteVerified postcodeAlexander City, United States· Recruiting
- Tenax Investigational SiteVerified postcodeTamarac, United States· Not yet recruiting
- Tenax Investigational SiteVerified postcodeMount Prospect, United States· Not yet recruiting
- Tenax Investigational SiteVerified postcodePeoria, United States· Recruiting
- Tenax Investigational SiteVerified postcodeNew Orleans, United States· Recruiting
- Tenax Investigational SiteVerified postcodeWest Monroe, United States· Recruiting
- Tenax Investigational SiteVerified postcodeYpsilanti, United States· Not yet recruiting
- Tenax Investigational SiteVerified postcodeReno, United States· Recruiting
- Tenax Investigational SiteVerified postcodeNew York, United States· Not yet recruiting
- Tenax Investigational SiteVerified postcodeWinston-Salem, United States· Recruiting
- Tenax Investigational SiteVerified postcodeAllentown, United States· Not yet recruiting
- Tenax Investigational SiteVerified postcodeWynnewood, United States· Not yet recruiting
Common questions
What is PH-HFpEF?
It's a combination of high blood pressure in the lungs and a type of heart failure where your heart struggles to fill with blood properly, even if its pumping action seems normal. This can make you feel very tired and breathless.
What is TNX-103?
TNX-103 (also called levosimendan) is the new oral medicine being tested in this study. It's meant to help improve how well your heart works and reduce symptoms of your condition.
What is a placebo?
A placebo is an inactive dummy pill that looks just like the study drug but contains no active medicine. It helps researchers understand if the study drug actually makes a difference compared to no treatment.
What is a 6-Minute Walk Test?
It's a simple test where you walk as far as you can in 6 minutes, usually along a marked corridor. It's a common way to measure how your condition affects your ability to exercise.
How long will I be in the study if I join?
The initial part of the study lasts for a set period. If you meet the criteria, you might then have the option to continue receiving the study drug for an additional year in an open-label extension phase.
How to find out more
Akshata Ashokkumar
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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