Summary

for people ages 18-79 (full criteria)
at UCLA UC Davis
study started
estimated completion:
Rajan Saggar (ucla) Roblee Allen (ucdavis)

Description

Summary

This is an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who have completed Study TDE-HF-301. This study will provide long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil becomes commercially available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.

Official Title

An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301

Keywords

Pulmonary Hypertension Associated With HFpEF Pulmonary Hypertension HFpEF 6-Minute Walk Test Oral Treprostinil Hypertension Heart Failure Hypertension, Pulmonary Treprostinil

Eligibility

You can join if…

Open to people ages 18-79

  • The subject participated in Study TDE-HF-301, remained on study drug, was compliant with study procedures and assessments during Study TDE-HF-301, and completed through Week 24 of that study.

You CAN'T join if...

  • The subject is pregnant or lactating.
  • The subject was prematurely discontinued from Study TDE-HF-301 for any reason.
  • The subject developed a concurrent illness or condition during Study TDE HF 301,which, in the opinion of the Investigator, would represent a risk to the subject's overall health if they enrolled in this study.

Locations

  • University of California Los Angeles Pulmonary Division accepting new patients
    Los Angeles California 90095 United States
  • University of California - Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • VA Healthcare System of Greater Los Angeles accepting new patients
    Los Angeles California 90073 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90211 United States

Lead Scientists

  • Rajan Saggar (ucla)
    Assistant Professor, Medicine. Authored (or co-authored) 70 research publications
  • Roblee Allen (ucdavis)
    Professor, Pulmonary, Critical Care, and Sleep Medicine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
United Therapeutics
ID
NCT03043651
Phase
Phase 3
Study Type
Interventional
Last Updated