Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)

This is an open-label study to evaluate the safety of continued therapy with oral
treprostinil in subjects who have completed Study TDE-HF-301. This study will provide
long-term, open-label data regarding the effect of continued long-term oral treprostinil
therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with
preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18,
24, and every 12 weeks thereafter until either oral treprostinil becomes commercially
available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.

Eligibility Criteria

Inclusion Criteria:

- The subject participated in Study TDE-HF-301, remained on study drug, was compliant
with study procedures and assessments during Study TDE-HF-301, and completed through
Week 24 of that study.

Exclusion Criteria

- The subject is pregnant or lactating.

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

- The subject developed a concurrent illness or condition during Study TDE HF 301,
which, in the opinion of the Investigator, would represent a risk to the subject's
overall health if they enrolled in this study.

Principal Investigator

Lewis Satterwhite

Study Contact

Paige Kallenberger, pkallenberger@kumc.edu, 913-588-4022

Estimated Completion Date

Wednesday, December 1, 2021

ClinicalTrials.gov #

NCT03043651
10/25/2017