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

This is a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind,
placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary
hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).
Once randomized, subjects will take the initial dose of study drug at the study site on the
day of randomization. Subjects will return to the study site for visits scheduled at Weeks 6,
12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.

Eligibility Criteria

Inclusion Criteria:

1. The subject has undergone a right heart catheterization (RHC) within 90 days of
randomization.

2. The subject has a diagnosis of heart failure with a left ventricular ejection fraction
(LVEF) ≥50%.

3. The subject's baseline 6MWD must be at least 200 meters.

4. The subject has pulmonary function tests conducted within 6 months of Screening or
during the Screening phase.

5. Subjects on a chronic medication for heart failure must be on a stable dose for ≥30
days prior to randomization.

Exclusion Criteria:

1. The subject is pregnant or lactating.

2. The subject has a diagnosis of pulmonary arterial hypertension (PAH) or PH other than
WHO Group 2 PH.

3. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or
prostacyclin analogue that resulted in discontinuation of therapy or inability to
effectively titrate that therapy.

4. The subject has received any approved PAH therapy within 60 days of randomization.

5. The subject has been hospitalized or visited an emergency department for a
cardiopulmonary indication within 30 days of randomization.

6. The subject had a myocardial infarction within 90 days of randomization.

7. The subject had cardiac resynchronization therapy within 3 months of randomization or
anticipated resynchronization therapy during the study treatment period.

8. The subject has liver function tests greater than 3 times the upper limit of normal at
Screening, clinically significant liver disease/dysfunction, known Child-Pugh Class C
hepatic disease, or noncirrhotic portal hypertension.

9. The subject has uncontrolled systemic hypertension, systolic blood pressure <100 mmHg,
or a resting heart rate >100 beats per minute.

10. The subject has known genetic hypertrophic cardiomyopathy, sarcoidosis, or cardiac
amyloidosis.

11. The subject has a known history of any LVEF less than 40% by echocardiogram (ECHO).

12. The subject has any of the following valvular diseases: mild, moderate, or severe
aortic and/or mitral stenosis, severe mitral and/or aortic regurgitation (>Grade 3) or
hemodynamically significant valvular disease

13. The subject has a Body Mass Index >40 kg/m^2.

14. The subject has any musculoskeletal disorder, or has any other condition that limits
ambulation.

15. The subject has end-stage renal disease requiring/receiving dialysis.

16. The subject participated in an investigational drug or device study within 30 days
prior to signing consent.

Principal Investigator

Lewis Satterwhite

Study Contact

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

Estimated Completion Date

Wednesday, July 1, 2020

ClinicalTrials.gov #

NCT03037580
10/25/2017