TerminatedPhase 3

Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction

Stopped: Terminated by sponsor

United States84 participantsStarted 2017-08-15

Plain-language summary

This was 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 took the initial dose of study drug at the study site on the day of randomization. Subjects returned to the study site for visits scheduled at Weeks 6, 12, 18, and 24. The duration of study participation was approximately 28 weeks from Screening until study completion (includes a 30-day Screening Phase and 24-week Treatment Phase). The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment. As only a small portion of the anticipated total subjects had been enrolled, with many terminating early due to the study termination, there was a limited ability to explore the effect of oral treprostinil in this indication in this study.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. The subject voluntarily gave informed consent to participate in the study.
✓. The subject was 18 to 85 years of age (inclusive) at Screening (ie, date of providing written informed consent).
✓. A subject could qualify if they had undergone a right heart catheterization (RHC) within 180 days of Baseline.
✓. The subject had a diagnosis of heart failure with a left ventricular ejection fraction (LVEF) ≥45% by ECHO completed during Screening (prior to randomization).
✓. The subject's baseline 6MWD was at least 150 meters.
✓. The subject had pulmonary function tests conducted within 6 months of Screening or during the Screening Phase.
✓. Subjects on a chronic medication for heart failure were on a stable dose for ≥30 days prior to randomization.
✓. In the opinion of the Investigator, the subject was able to communicate effectively with study personnel, and was considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.

Exclusion criteria

What they're measuring

Change in 6MWD From Baseline to Week 24

Timeframe: Baseline to Week 24

Trial details

NCT IDNCT03037580

SponsorUnited Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-03

Results submitted2020-09-25

View on ClinicalTrials.gov More Pulmonary Hypertension trials