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Trials / Active Not Recruiting

Active Not RecruitingNCT05203510

A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension

A Phase 4, Prospective, Multicenter, Single-Arm Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Patients With Pulmonary Arterial Hypertension: ARTISAN (Afterload Reduction To Improve Right Ventricular Structure And FuNction)

Status
Active Not Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
52 (actual)
Sponsor
United Therapeutics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The primary objective of this study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in participants with pulmonary arterial hypertension (PAH).

Conditions

Interventions

TypeNameDescription
DRUGParenteral TreprostinilParenteral treprostinil will be administered per schedule specified in the arm description.
DRUGOral TreprostinilOral treprostinil will be administered per schedule specified in the arm description.

Timeline

Start date
2022-10-20
Primary completion
2026-04-30
Completion
2028-04-30
First posted
2022-01-24
Last updated
2025-12-09

Locations

28 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05203510. Inclusion in this directory is not an endorsement.