Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
This research study is an extension of a previous trial, designed to learn more about a new medicine called sotatercept. It's for people who have a particular type of high blood pressure in their lungs, known as combined postcapillary and precapillary pulmonary hypertension (Cpc-PH), which is caused by a specific kind of heart failure (HFpEF). If you've already taken part in a related study on sotatercept for Cpc-PH, you might be able to join this one. The main aim is to understand the long-term effects of sotatercept, specifically its safety and whether people can take it comfortably over a longer period. This will help doctors understand if sotatercept is a good long-term treatment option for this condition.
At a glance
What is this study about?
This research study is looking into a new treatment called sotatercept for a specific condition. This condition is a type of high blood pressure in the arteries of the lungs, called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This particular type of Cpc-PH is linked to a form of heart failure where the heart pumps blood normally but has trouble relaxing and filling with blood properly, known as heart failure with preserved ejection fraction (HFpEF).
If you've previously taken part in a study testing sotatercept for Cpc-PH, you might be invited to join this extension study. It's designed to let researchers follow your health for a longer time while you continue to receive sotatercept. The main intention of this extended research is to gather more information about the medicine's safety over time and to see if people tolerate it well when taken for a longer duration.
The findings from this study will help healthcare professionals understand if sotatercept could be a valuable and safe long-term treatment option for individuals living with this specific type of pulmonary hypertension caused by heart failure. This is important as new and effective treatments are always being sought for complex conditions like Cpc-PH.
Key takeaways
- This study is for a specific type of high blood pressure in the lungs (Cpc-PH) caused by heart failure.
- It's an 'extension study' for people who were in a previous trial with the drug sotatercept.
- The main aim is to check the long-term safety and tolerability of sotatercept.
- Participants will continue to receive the study drug and have their health monitored.
- You must have completed the initial 'CADENCE' study to be eligible.
Who may be eligible?
To be considered for this study, you must have already completed a specific previous study about sotatercept for Cpc-PH (called the MK-7962-007 study, also known as CADENCE). You need to have finished that study without stopping the treatment early and be well enough to safely join this new, extended study.
There are certain health conditions or situations that would prevent someone from joining. For example, if you have other types of high blood pressure in the lungs (called WHO Group 1, 3, 4, or 5 PH) that are not the focus of this study. You also can't join if you are pregnant or breastfeeding, or if you have severe chronic liver disease, especially if you have had things like hepatic encephalopathy (a brain condition due to liver disease) or cirrhosis.
Changes to your heart valves, having more than one valve replacement or repair, a history of or planned heart transplant, or a device to help your heart pump blood would also mean you can't take part. Additionally, if you've had a break from your study medicine in the past, or if you have previously been given a different medicine called luspatercept, you wouldn't be able to join this study. Participants must be 18 years or older.
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.
- Did you complete the previous 'CADENCE' study (MK-7962-007)?
- Are you 18 years old or older?
- Do you have Cpc-PH related to heart failure with preserved ejection fraction (HFpEF)?
- Are you not pregnant or breastfeeding?
- Do you not have severe liver disease or any current liver problems like hepatic encephalopathy?
- Have you not had more than one heart valve replacement/repair, a heart transplant, or a ventricular assist device?
What does participation involve?
As this is an extension study, you would continue to receive the study medicine, sotatercept. Researchers will regularly check your health, likely through clinic visits, physical examinations, and possibly blood tests or other scans, to monitor how you are doing over time. This helps them understand the long-term safety of the medicine and how well your body tolerates it. The exact number and frequency of visits, as well as the total duration of your participation, would be clearly explained by the study team, but the aim is longer-term follow-up than the initial study.
Potential risks and benefits
Locations (57)
- Pulmonary Associates, PA ( Site 1008)Verified postcodePhoenix, United States· Active not recruiting
- Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004)Verified postcodeLa Jolla, United States· Active not recruiting
- Jeffrey S. Sager, MD Medical Corporation ( Site 1060)Verified postcodeSanta Barbara, United States· Active not recruiting
- Stanford University Medical Center ( Site 1024)Verified postcodeStanford, United States· Active not recruiting
- South Denver Cardiology Associates ( Site 1091)Verified postcodeLittleton, United States· Active not recruiting
- Yale New Haven Hospital ( Site 1093)Verified postcodeNew Haven, United States· Active not recruiting
- AdventHealth Orlando ( Site 1058)Verified postcodeOrlando, United States· Active not recruiting
- The Emory Clinic ( Site 1030)Verified postcodeAtlanta, United States· Active not recruiting
- Norton Pulmonary Specialists ( Site 1066)Verified postcodeLouisville, United States· Active not recruiting
- University Of Nebraska Medical Center ( Site 1053)Verified postcodeOmaha, United States· Active not recruiting
- Weill Cornell Medical Center ( Site 1046)Verified postcodeNew York, United States· Active not recruiting
- Duke University Medical Center ( Site 1026)Verified postcodeDurham, United States· Recruiting
Common questions
What is Cpc-PH?
Cpc-PH is a specific type of high blood pressure in the lungs, which in this study, is linked to a form of heart failure where the heart struggles to relax and fill properly.
What is sotatercept?
Sotatercept is the new medicine being investigated in this study as a potential treatment for Cpc-PH.
Why is this an 'extension study'?
It's an extension study because it's for people who have already taken part in a previous study about sotatercept. It allows researchers to follow participants for a longer time.
What is the main goal of this study?
The main goal is to find out about the long-term safety of sotatercept and how well people tolerate it over an extended period.
Do I need to have been in another study to join?
Yes, you must have completed a specific previous study (MK-7962-007 or CADENCE) about sotatercept to be considered for this extension study.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
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