What is the purpose of this clinical research study?
The main purpose of this study is to determine whether the investigational medication used in this clinical research study may help improve your pulmonary hypertension.
How do I know if I am eligible?
You may be eligible to participate if:
- if you are a man or woman 18 years of age or older and
- have been told by your doctor that you have severe pulmonary hypertension, including idiopathic pulmonary arterial hypertension (IPAH), heritable pulmonary arterial hypertension (HPAH), drug and toxin induced PAH, or PAH associated with connective tissue disease, or congenital heart defects
- your doctor classified your functional status as WHO Function Class III
Other study criteria will be assessed at a screening visit.
Is there a placebo (an inactive substance)?
No, there is no placebo used in this study. Everyone in this study receives the investigational medication.
Is this a blinded study or an open label study?
This study is not blinded, it is an open label study. This means that both participants and their study doctor will know which treatment patients are receiving.
What should I expect if I join the study?
You will be given information about the study and have the opportunity to ask questions, so that you can decide if you want to participate.
- If you decide to take part in the study, you will sign the informed consent form which acknowledges your willingness to participate.
- The study team will ask you to attend a screening visit to determine if your diagnosis is a good match for the study.
- The amount of time patients will be in the study varies. You will remain in the study for as long as the study medication is of benefit to you or if you decide to withdraw from treatment. If you decide to stop treatment or the investigational medication is no longer of benefit, the next step in the study is to follow your condition overtime unless you decide to withdraw from any further participation in the study.
- Taking part in this study may or may not improve your condition. There may be no benefit to you. There is a possibility that your condition may remain the same or get worse. There is also a possibility you will experience side effects, which may be serious, with the study medication. While you are in the study the study doctor will follow your condition closely.
Is there any cost for participating?
Eligible study participants will receive study-related procedures and study medication at no charge.
What if I change my mind?
Your taking part in this study is voluntary. You do not have to be in this research study. You can agree to be in the study now and change your mind later. You may stop your participation at any time. Your decision will not affect your regular care.