TDE-HF-301 Follow-up

Multi-center, open-label study for eligible patients who completed Study TDE-HF-301. The primary objective of this study is to evaluate the long-term safety of oral treprostinil in subjects with PH associated with HFpEF for subjects who completed Study TDE-HF-301. The secondary objective of this study is to assess the effect of continued long-term therapy with oral treprostinil on the following:

• 6-Minute Walk Distance (6MWD)
• Borg dyspnea score
• World Health Organization (WHO) Functional Class
• N-Terminal pro-brain natriuretic peptide (NT-proBNP) at Weeks 24 and 48.

Inclusion Criteria

• The subject voluntarily gives informed consent to participate in the study 

Exclusion Criteria

• The subject was prematurely discontinued from Study TDE-HF-301 for any reason.

Study Requirements

• Your vital signs will be collected (weight, blood pressure, breathing and heart rate, and the amount of oxygen in your blood)
• If you are using oxygen, the amount of oxygen you are using will be collected
• Your current medications and current illnesses will be reviewed
• A urine pregnancy test will be performed if you are a woman of childbearing potential
• About 3-4 teaspoons of blood will be drawn for routine clinical laboratory tests at all visits and a test called an NT-pro-BNP at Weeks 24 and 48 only
• Measurement of your exercise capacity (6 Minute Walk Test)
• Your study drug diary and any used and unused bottles of study drug will be collected
• You will be given new study drug, diary, and supplies
• If necessary, your study drug dose will be adjusted