Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction

Inclusion Criteria:

1. The subject voluntarily gave informed consent to participate in the study.
2. The subject was 18 to 85 years of age (inclusive) at Screening (ie, date of providingwritten informed consent).
3. A subject could qualify if they had undergone a right heart catheterization (RHC)within 180 days of Baseline.
4. The subject had a diagnosis of heart failure with a left ventricular ejection fraction (LVEF) ≥45% by ECHO completed during Screening (prior to randomization).
5. The subject's baseline 6MWD was at least 150 meters.
6. The subject had pulmonary function tests conducted within 6 months of Screening orduring the Screening Phase.
7. Subjects on a chronic medication for heart failure were on a stable dose for ≥30 daysprior to randomization.
8. In the opinion of the Investigator, the subject was able to communicate effectivelywith study personnel, and was considered reliable, willing, and likely to becooperative with protocol requirements, including attending all study visits.
9. Women of childbearing potential, including any female who had experienced menarche andwho had not undergone successful surgical sterilization or was not postmenopausal,must have practiced true abstinence from intercourse when it was in line with theirpreferred and usual lifestyle, or have used 2 different forms of highly effectivecontraception for the duration of the study, and for at least 30 days afterdiscontinuing study drug. Male subjects with a partner of childbearing potential musthave used a condom during the length of the study, and for at least 48 hours afterdiscontinuing study drug.
10. Subjects on chronic medications (eg, inhaled corticosteroids, long-acting beta2adrenergic agonist, long acting muscarinic antagonists, combination inhaled drugs,anti-inflammatory drugs, oral/parenteral corticosteroids, or biologic agents) for anyunderlying respiratory condition were on a stable dose for ≥30 days prior torandomization.

Exclusion Criteria:

1. The subject was pregnant or lactating.
2. In the opinion of the Principal Investigator, the subject had a primary diagnosis ofPH other than WHO Group 2 PH.
3. The subject had shown intolerance or significant lack of efficacy to a prostacyclin orprostacyclin analogue that resulted in discontinuation of therapy or inability toeffectively titrate that therapy.
4. The subject had received any approved pulmonary arterial hypertension (PAH) therapieswithin 30 days of randomization. Chronic use of an approved phosphodiesterase type 5inhibitor (PDE5-I) was allowed as long as the subject has been on a stable dose for atleast 90 days prior to randomization and had a RHC confirming the parameters necessaryfor inclusion in the study after being on a stable PDE5-I dose for at least 30 days.
5. The subject had been hospitalized for a cardiopulmonary indication within 30 days ofrandomization.
6. The subject had a myocardial infarction within 90 days of randomization.
7. The subject had cardiac resynchronization therapy within 90 days of randomization oranticipated resynchronization therapy during the study treatment period.
8. The subject had liver function tests greater than 3 times the upper limit of normal atScreening, clinically significant liver disease/dysfunction, known Child-Pugh Class Chepatic disease, or noncirrhotic portal hypertension.
9. The subject had uncontrolled systemic hypertension, systolic blood pressure <100 mmHg,or a resting heart rate >100 beats per minute at Baseline.
10. The subject had known genetic hypertrophic cardiomyopathy, sarcoidosis, or cardiacamyloidosis.
11. The subject had a known history of any LVEF less than 40% by ECHO within 3 years ofrandomization. Note: a transient decline in LVEF below 40% that occurred and recoveredmore than 6 months before the start of Screening and was associated with an acuteintercurrent condition (eg, atrial fibrillation) was allowed.
12. The subject had hemodynamically significant valvular heart disease as determined bythe Investigator, including: greater than mild aortic and/or mitral stenosis or severemitral and/or aortic regurgitation (>Grade 3)
13. The subject had a Body Mass Index >45 kg/m^2.
14. The subject had any musculoskeletal disorder, or had any other condition that limitedambulation.
15. The subject had end-stage renal disease requiring/receiving dialysis.
16. The subject participated in an investigational drug or device study within 30 daysprior to the first dose of study drug.