Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept versus Placebo-Controlled for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)
This research study is investigating a new medication called sotatercept. It's for people who have a specific type of high blood pressure in their lungs, known as Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH). This lung condition is caused by a particular kind of heart weakness where the heart struggles to pump blood effectively, called Heart Failure with Preserved Ejection Fraction (HFpEF). The main goal is to find out if sotatercept can reduce the pressure in the lung blood vessels after 24 weeks, compared to a placebo (a dummy drug). Researchers will also look at how patients feel, their need for hospital visits, and how well they can walk.
At a glance
What is this study about?
This study is looking into a new treatment for a complex heart and lung condition. Imagine your heart as a pump that sends blood around your body. Sometimes, even if the pump itself looks strong, it can struggle to relax properly between beats. This makes it harder for blood to fill the heart, leading to a build-up of pressure. When this happens, it's called Heart Failure with Preserved Ejection Fraction, or HFpEF.
This build-up of pressure can then affect the blood vessels in your lungs, causing high blood pressure there. This specific type of high blood pressure in the lungs is known as Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH). It can make you feel breathless and tired.
Researchers are testing a new medicine called sotatercept. They want to see if this medicine can help lower the high blood pressure in the lungs for people with Cpc-PH caused by HFpEF. They'll be comparing it to a placebo (a dummy drug) to truly understand its effects. If successful, this new medication could offer a new way to help people manage this challenging condition.
Key takeaways
- This study is for a new medicine called sotatercept.
- It's for high blood pressure in the lungs (Cpc-PH) caused by a specific type of heart failure (HFpEF).
- The study lasts 24 weeks and compares the medicine to a placebo.
- Researchers want to see if the medicine improves lung pressure and symptoms.
- Participation involves regular clinic visits, tests, and injections.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Crucially, you must have been diagnosed with Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) that is caused by Heart Failure with Preserved Ejection Fraction (HFpEF). The study team will perform tests to confirm you have these specific conditions.
There will also be other health checks and medical requirements that the study doctors will go through with you to make sure the study is safe and suitable for your individual health situation.
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?
- Have you been diagnosed with high blood pressure in your lungs (Cpc-PH)?
- Is your lung condition caused by a specific type of heart failure (HFpEF)?
- Are you able to attend regular clinic appointments for about six months?
- Are you comfortable with receiving injections?
What does participation involve?
If you decide to take part, you'll be given either the new medicine (sotatercept) or a placebo, which looks identical but contains no active drug. You won't know which one you're receiving, and neither will your study doctor, until the end of the research. Both are given as injections.
Over 24 weeks, you'll have regular visits to the clinic for various tests. These will include blood pressure checks, blood tests, and scans of your heart (echocardiograms) to see how it's working. You'll also likely do walking tests to see how your exercise ability changes, and regularly answer questions about how you're feeling and your symptoms. The study team will monitor your health closely throughout this period.
Potential risks and benefits
Locations (7)
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Common questions
What is Cpc-PH?
Cpc-PH is a type of high blood pressure in the lungs that is caused by heart problems.
What is HFpEF?
HFpEF is a type of heart failure where your heart struggles to fill with blood properly, even though it can still pump blood out well.
What does 'double-blind' mean?
It means neither you nor your doctor will know if you're getting the study medicine or the dummy treatment.
How long will the study last?
The main part of the treatment and observation period for this study is 24 weeks, which is about six months.
Will I get an active drug or a placebo?
You will be randomly assigned to receive either the study medicine (sotatercept) or a placebo (dummy drug). You won't know which one you're getting.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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