Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients

This study is looking for adults aged between 18 and 70 years old who have just been diagnosed with certain types of pulmonary arterial hypertension (PAH) or haven't been treated for it in the last three months. These types include PAH that doesn't have a clear cause (idiopathic), PAH that runs in families (hereditary), PAH caused by medicines or toxins, PAH linked to connective tissue diseases, or PAH with a repaired heart defect from birth.

You might be able to join if your PAH is considered 'intermediate-high risk' or 'intermediate-low risk' but with some severe signs of how your heart and lungs are working. Doctors will do some tests, including a special heart catheterisation, to check your heart and lung pressures and confirm your diagnosis.

However, you won't be able to join if you have certain other types of PAH (like those linked to schistosomiasis, HIV, liver problems, or a widespread skin condition called diffuse systemic sclerosis) or if your heart defect from birth hasn't been fixed. You also can't participate if you've already had PAH-specific treatment recently, if your PAH responds to certain tablets called calcium channel blockers, or if you have certain other lung or heart conditions.

If you decide to take part in the TripleTRE study, you'll be randomly assigned to one of two treatment groups, like flipping a coin. You'll receive either two oral medications or the same two oral medications along with treprostinil, which is given by an injection. All medicines will be started within three weeks of joining the study. You'll have regular visits to the hospital for check-ups, tests, and to monitor how you're feeling and how the treatment is working. This will include blood tests, heart and lung function tests, and possibly repeats of the heart catheterisation. The study will follow your progress for about 24 to 48 weeks, which is roughly between six months and a year.