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)

  • STATUS
    Recruiting
  • sponsor
    United Therapeutics
Updated on 25 March 2021

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
Clinical Study IdentifierTX152559
SponsorUnited Therapeutics
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

RHC within 90 days of randomization
Diagnosis of PAH or PH in WHO Group 2
Heart failure diagnosis with a LVEF >50%
PFT's within 6 months- TLC and FEV1 at least 60% of predicted value
Taking chronic, stable heart failure medications
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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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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