A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
The APEX study is testing a new medicine, TX000045, for people who have high blood pressure in their lungs (pulmonary hypertension) because of a specific kind of heart failure (heart failure with preserved ejection fraction). This is a 'Phase 2' study, which means it's an early stage to see if the medicine works and is safe. Participants will be given either one of two different doses of TX000045 or a placebo (a dummy treatment) for 24 weeks. The medicine will be given as an injection under the skin every two weeks. The aim is to understand if TX000045 can improve their condition and how well it is tolerated.
At a glance
What is this study about?
This study, called the APEX study, is all about finding new ways to help people living with a specific health challenge. It focuses on individuals who have 'pulmonary hypertension' – that's when there's high blood pressure in the arteries leading from your heart to your lungs. This particular study is for people whose pulmonary hypertension is caused by a type of heart failure known as 'heart failure with preserved ejection fraction.' This means your heart can still pump blood out well, but it doesn't relax properly to fill with enough blood.
The researchers are testing a new medicine, called TX000045. This medicine is still in an early stage of development (called 'Phase 2'), which means doctors are looking to see if it's safe and if it shows promise in helping patients. They want to understand if different doses of this medicine can make a difference to people's health compared to a placebo, which is a dummy treatment with no active medicine, like a sugar pill. This helps them know if any changes are truly due to the new medicine.
The goal of this research is to see if TX000045 could potentially be a treatment option in the future for people with this specific combination of heart and lung conditions. By taking part, you would be contributing to valuable medical knowledge that could help many others down the line.
Key takeaways
- The APEX study is for adults with high blood pressure in the lungs caused by a specific type of heart failure.
- It tests a new medicine, TX000045, against a dummy treatment (placebo).
- Participation involves receiving injections every two weeks and regular clinic visits over 24 weeks.
- You might receive the new medicine or a placebo; neither you nor your doctor will know which until the study ends.
- The study aims to see if TX000045 is safe and helps improve symptoms.
Who may be eligible?
The study is looking for adults between 18 and 83 years old. You would need to have been diagnosed with pulmonary hypertension linked to heart failure where your heart's pumping ability is still good, and you have some symptoms of heart failure that affect your everyday life.
There are also some reasons why you might not be able to join. For example, if you have other specific types of pulmonary hypertension, have been in hospital recently for your heart, or have certain other serious health problems like significant liver disease, kidney problems, or uncontrolled diabetes. You also can't be pregnant or breastfeeding. Certain medications taken recently, or a history of drug or alcohol abuse, would also prevent participation.
The research team will carry out several checks and tests to make sure that taking part in this study is suitable and safe for you. They will review all your medical information carefully before you can join.
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 83 years old?
- Have you been diagnosed with high blood pressure in your lungs due to a specific type of heart failure?
- Do you have heart failure symptoms that affect your daily life?
- Are you willing to attend regular clinic visits and receive injections every two weeks?
- Are you generally in stable health (with no recent hospitalisations or other serious illnesses)?
- Are you not pregnant or breastfeeding?
What does participation involve?
If you join the study, you'll be part of it for about 24 weeks, which is roughly six months. You'll be assigned by chance to one of three groups: one group will get a dummy treatment (placebo), and the other two groups will get different doses of the study medicine, TX000045. No one, not even your doctors, will know which treatment you are receiving until after the study ends.
The medicine (or placebo) will be given as an injection under your skin every two weeks. You'll have regular visits to the clinic for medical check-ups, blood tests, and other assessments to see how you're doing and if the treatment is having any effect. These visits will help the doctors monitor your health and how you respond to the treatment. It's important to attend all scheduled appointments.
Potential risks and benefits
Locations (86)
- PhoenixVerified postcodePhoenix, United States· Recruiting
- ScottsdaleVerified postcodeScottsdale, United States· Recruiting
- San FranciscoVerified postcodeSan Francisco, United States· Recruiting
- Santa RosaVerified postcodeSanta Rosa, United States· Recruiting
- AuroraVerified postcodeAurora, United States· Recruiting
- JacksonvilleVerified postcodeJacksonville, United States· Recruiting
- TampaVerified postcodeTampa, United States· Recruiting
- AugustaVerified postcodeAugusta, United States· Recruiting
- McDonoughVerified postcodeMcDonough, United States· Recruiting
- BoiseVerified postcodeBoise, United States· Recruiting
- ChicagoVerified postcodeChicago, United States· Recruiting
- IndianapolisVerified postcodeIndianapolis, United States· Recruiting
Common questions
What is 'pulmonary hypertension secondary to heart failure'?
It means you have high blood pressure in the arteries going to your lungs, and this is happening because of a specific type of heart failure where your heart struggles to relax properly.
What is TX000045?
TX000045 is an experimental medicine being tested in this study. It's not yet approved for general use but is being investigated to see if it can help people with your condition.
What is a 'placebo'?
A placebo is a dummy treatment. It looks just like the real medicine but contains no active ingredients. It helps researchers compare if the new medicine works better than no medicine at all.
How will I receive the medicine?
The study medicine or placebo will be given as an injection just under your skin, every two weeks, for the duration of the study.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason. Your decision will not affect your future medical care.
How to find out more
Clinical Trials
Always speak to your GP or specialist before deciding to take part in a study.
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