TDE-HF-301

Condition: Pulmonary hypertension, heart failure

Eligibility

Key Inclusion Criteria

  • 18–85 years old
  • Has undergone a right heart catheterization within 180 days of baseline assessment
  • Diagnosis of heart failure with a left ventricular ejection fraction ≥45%

Key Exclusion Criteria

  • Pregnant or lactating
  • Has a primary diagnosis of pulmonary hypertension other than World Health Organization Group 2 pulmonary hypertension
  • Intolerance or significant lack of response to a prostacyclin or prostacyclin equivalent

Full Study Name

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) in Heart Failure With Preserved Ejection Fraction (HFpEF) (IRB no. 48420)

Summary

This study focuses on individuals who have pulmonary hypertension (PH) associated with left-sided heart failure with preserved ejection fraction (HFpEF). PH associated with HFpEF causes high blood pressure in the lungs due to the heart’s inability to function properly. The purpose of the study is to evaluate how oral treprostinil works to treat this condition. Researchers will examine the effect of oral treprostinil on the participant’s ability to exercise, as well as the time that PH associated with HFpEF remains stable, improves, or worsens.

Participants will be randomly assigned to receive either oral treprostinil or placebo (inactive substance). Oral treprostinil is approved by the U.S. Food and Drug Administration for the treatment of pulmonary arterial hypertension, a specific type of PH, but the use of oral treprostinil in this study is investigational.

Phase

Phase III

Principal Investigator

Antoine Hage, MD

Contact
Savannah Mersola
Phone: 310-248-7107
Email: savannah.mersola@csmns.org