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

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT03037580

Background Information

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.

Offered At

Inova Fairfax Hospital

3300 Gallows Road

Falls Church, VA 22042

Principal Investigator

Dr. Mardi Gomberg

Eligibility Information

Inclusion Criteria:

  • The subject has undergone a right heart catheterization (RHC) within 90 days of Screening.
  • The subject has a diagnosis of heart failure with a left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO).
  • The subject's baseline 6MWD must be at least 200 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.

Ineligibility Information

Exclusion Criteria:

  • The subject is pregnant or lactating.
  • The subject has a diagnosis of pulmonary arterial hypertension (PAH) or 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 therapy within 60 days of randomization.
  • The subject has been hospitalized or visited an emergency department for a cardiopulmonary indication within 30 days of randomization.
  • The subject had a myocardial infarction within 90 days of randomization.
  • The subject had cardiac resynchronization therapy within 3 months 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 amyloidosis.
  • The subject has a known history of any LVEF less than 40% by ECHO within 3 years of randomization.
  • 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 >40 kg/m^2.
  • The subject has any musculoskeletal disorder, or has any other condition that limits ambulation.
  • 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.