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18 to 79 years old
Drug study, Phase 3
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.
Who can participate
A subject can qualify if they have undergone a right heart catheterization (RHC)
within 180 days of Baseline.
The subject has a diagnosis of heart failure with a left ventricular ejection fraction
(LVEF) ≥45% by echocardiogram (ECHO) completed during Screening (prior to
The subject's baseline 6MWD must be at least 150 meters.
The subject has pulmonary function tests conducted within 6 months of Screening or
during the Screening phase.
Subjects on a chronic medication for heart failure must be on a stable dose for ≥30
days prior to randomization.
Subjects on chronic medications for any underlying respiratory condition must be on a
stable dose for ≥30 days prior to randomization.
The subject is pregnant or lactating.
In the opinion of the Principal Investigator, the subject has a primary diagnosis of
PH other than WHO Group 2 PH.
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.
The subject has received any approved PAH therapies within 30 days of randomization.
Chronic use of an approved phosphodiesterase type 5 inhibitor (PDE5-I) is allowed as
long as the subject has been on a stable dose for at least 90 days prior to
randomization and has had an RHC confirming the parameters necessary for inclusion in
the study after being on a stable PDE5-I dose for at least 30 days.
The subject has been hospitalized for a cardiopulmonary indication within 30 days of
The subject had a myocardial infarction within 90 days of randomization.
The subject had cardiac resynchronization therapy within 90 days of randomization or
anticipated resynchronization therapy during the study treatment period.
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.
The subject has uncontrolled systemic hypertension, systolic blood pressure <100 mmHg,
or a resting heart rate >100 beats per minute at Baseline.
The subject has known genetic hypertrophic cardiomyopathy, sarcoidosis, or cardiac
The subject has a known history of any LVEF less than 40% by ECHO within 3 years of
randomization. Note: a transient decline in LVEF below 40% that occurred and recovered
more than 6 months before the start of Screening and was associated with an acute
intercurrent condition (eg, atrial fibrillation) is allowed.
The subject has hemodynamically significant valvular heart disease as determined by
the Investigator, including: greater than mild aortic and/or mitral stenosis or severe
mitral and/or aortic regurgitation (>Grade 3)
The subject has a Body Mass Index >45 kg/m^2.
The subject has any musculoskeletal disorder, or has any other condition that limits
The subject has end-stage renal disease requiring/receiving dialysis.
The subject participated in an investigational drug or device study within 30 days
prior to signing consent.