Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pulmonary Arterial Hypertension
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: All participants will receive Treprostinil 2-3 times per day as tolerated. Subsequently, participants will receive Riociguat at 0.5 mg taken orally three times a day. Participants will receive the first dose inpatient prior to discharge. Participants will continue on a 2 ng/kg/min increase every other day for one week. Riociguat will subsequently be increased by 0.5 mg taken orally three times a day the following week as tolerated. Increases in Treprostinil and Riociguat will then alternate weeks such that only one medication is changed per week. Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The purpose of this study is to evaluate the combined effect of parenteral treprostinil (TRE) and riociguat (RIO) versus parenteral TRE alone on right ventricular (RV)-pulmonary artery (PA) interaction (RVPA coupling) and global RV function in patients with advanced pulmonary arterial hypertension (...
The purpose of this study is to evaluate the combined effect of parenteral treprostinil (TRE) and riociguat (RIO) versus parenteral TRE alone on right ventricular (RV)-pulmonary artery (PA) interaction (RVPA coupling) and global RV function in patients with advanced pulmonary arterial hypertension (PAH).
Tracking Information
- NCT #
- NCT04062565
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Franz Rischard, DO University of Arizona
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