The purpose of this study is to determine if there is a greater effect to patients with advanced pulmonary arterial hypertension (PAH) by using a combination of two drugs, Treprostinil and Riociquat versus Treprostinil alone
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Injection
Tablet
University of Arizona
Tucson, Arizona, United States
RECRUITINGChange in stroke volume/end systolic volume (SV/ESV)
Change in stroke volume/end systolic volume (SV/ESV)
Time frame: Baseline to 3 months
Change in pulmonary and cardiac pressures
Increase or decrease in pressures
Time frame: Baseline to 3 months
Change in pulmonary blood flow
Increase or decrease in pulmonary blood flow
Time frame: Baseline to 3 months
Change in end-systolic elastance/arterial elastance (Ees/Ea)
Change in the interaction of the right heart and lung blood vessels
Time frame: Baseline to 3 months
Change in Right Ventricle (RV) diastolic stiffness (Beta)
Change in how stiff the wall of the right heart is at the end of relaxation
Time frame: Baseline to 3 months
Change in 6 minute walk distance
Change in how far a participant can walk during a self paced 6 minute walk test
Time frame: Baseline to 3 months
Change in brain natriuretic peptide (BNP)
Change in biomarker BNP that examines stretch on the right heart
Time frame: Baseline to 3 months
Change in magnetic resonance imaging (MRI) right ventricle volumes
Change in the volume ejected per beat and the end systolic and diastolic values of the right heart
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Time frame: Baseline to 3 months
Change in Cardio pulmonary Exercise Testing (CPET)
Change in how much oxygen the body consumes at peak exercise
Time frame: 3 months
Change in derived VO2 max
Change in how much oxygen the body consumes at peak exercise
Time frame: 3 months
Change in derived Ve/VCO2
Change in how much oxygen the body consumes at peak exercise
Time frame: 3 months
Change in adverse event profile
Change in side effects or other adverse events between combination therapy and historical control
Time frame: Baseline to 3 months
Change in composite time to clinical worsening
Difference relative to historical control in the time from diagnosis to followup, hospitalization, death or transplant
Time frame: Baseline to 3 months