Actively Recruiting
Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH
Led by University of Arizona · Updated on 2025-02-20
20
Participants Needed
1
Research Sites
353 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of WHO Category I pulmonary arterial hypertension (PAH)
- Resting mean pulmonary artery pressure (mPAP) of 25 mmHg or higher with wedge pressure of 15 mmHg or less during right heart catheterization
- Need for parenteral Treprostinil as determined by a pulmonary hypertension specialist
You will not qualify if you...
- Mean arterial pressure below 60 or requiring vasopressor support
- Expected need for device assistance (ECMO, RVAD) or early lung transplant within 3 months
- Left ventricular ejection fraction below 50% or heart failure with preserved ejection fraction or moderate to severe valve abnormalities
- Severe restrictive lung disease (FVC less than 70% predicted) or obstructive lung disease (FEV1 less than 70% predicted and FEV1/FVC less than 70%)
- Pulmonary embolism within last 3 months or chronic pulmonary embolism
- Contraindication to right heart catheterization
- Use of active or previous pulmonary vasoactive medication within 12 weeks
- PAH with significant venous or capillary involvement (PCWP over 15 mmHg), pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis
- Pulmonary hypertension groups 2 to 5 of WHO classification
- Moderate to severe liver impairment (Child-Pugh Class B or C)
- Creatinine clearance less than 30 mL/min
- Elevated liver enzymes (AST or ALT over 1.5 times upper limit)
- Hemoglobin less than 75% of normal lower limit
- Physical impairment limiting study compliance other than dyspnea
- Pregnant or breastfeeding; females must abstain from intercourse or use two forms of contraception during study and 30 days after
- Life expectancy less than 12 months due to other life-threatening disease
- Body weight under 40 kg or over 150 kg
- Any condition preventing adherence to protocol
- Concurrent use of strong CYP3A4 inhibitors/inducers or medications that may increase Riociguat's hypotensive effect
- Nitrate treatment within 4 weeks prior to enrollment
- Known hypersensitivity to Treprostinil or Riociguat or their components
- Use of another investigational drug within 1 month prior to randomization
- Recent hemoptysis within 6 months or history of severe hemoptysis requiring intervention
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
Research Team
V
Valerie Boss, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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