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TDE-HF-301 Follow-up


Title An Open-label Extension Study of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) Associated with Heart Failure with Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301
Therapeutic Area Pulmonary Hypertension
Principal Investigator Ioana Preston, MD
Min Age 18 Years
Max Age 85 Years
Gender All
Contact Karen Visnaw, RN
6176361334
More Information https://www.clinicaltrials.gov/ct2/show/NCT3043651

Overview

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.

Study Details

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