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)
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- STATUS
- Recruiting
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- sponsor
- United Therapeutics
Summary
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)
Description
The primary objective of this study is to assess the effect of oral treprostinil compared with placebo on change in exercise capacity as measured by change in 6MWD from Baseline to Week 24 in subjects with PH associated with HFpEF. There are no approved treatments for PH in subjects with left heart disease; however, the efficacy of therapies in WHO Group 1 PAH, along with lack of evidence-based therapies available for the treatment of HFpEF, have stimulated further investigation in this indication.
If patients qualify, all study procedures including lab work, tests, study visits, and the study drug are provided to you free of charge by the sponsor
Details
| Condition | Pulmonary Arterial Hypertension, Heart Failure |
|---|---|
| Clinical Study Identifier | TX152559 |
| Sponsor | United Therapeutics |
| Last Modified on | 25 March 2021 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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