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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
Full 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 (PAH).
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Inclusion criteria
Exclusion criteria
Patients with a mean arterial pressure <60, and/or requiring vasopressor support
Patients whom expected device (i.e. ECMO, RVAD) assistance or early pulmonary transplantation (within 3 months) seems inevitable
Patients with a left ventricular ejection fraction <50% or clinical, echocardiographic, and/or catheterization data consistent with heart failure with preserved ejection fraction (HFpEF) and/or moderate-severe aortic or mitral valve abnormality
Patients with severe restrictive lung disease (FVC<70% predicted) and/or obstructive lung disease (FEV1 <70% predicted and FEV1/FVC <70%).
Patients with a history of pulmonary embolism within the last three months or evidence of chronic pulmonary embolism.
Patients with a known contraindication to right heart catheterization.
Patients whom have received active or previous pulmonary vasoactive medication within the previous 12 weeks.
PAH associated with significant venous or capillary involvement (PCWP > 15 mmHg), known pulmonary veno-occlusive disease, and pulmonary capillary hemangiomatosis.
Pulmonary Hypertension belonging to groups 2 to 5 of the WHO classification.
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
Estimated creatinine clearance < 30 mL/min
Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal.
Hemoglobin < 75% of the lower limit of the normal range.
Acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements.
Pregnant or breast-feeding.
Known concomitant life-threatening disease with a life expectancy < 12 months.
Body weight < 40 kg and/or >150 kg.
Any condition that prevents compliance with the protocol or adherence to therapy.
Concurrent therapy with strong CYP3A4 inhibitors/inducers (i.e. protease inhibitors, azole antibiotics, macrolides), theophylline, and any medication in the PI's opinion may substantially potentiate the hypotensive effect of RIO.
Treatment with nitrates of any kind within the 4 weeks prior to enrollment.
Known hypersensitivity to drugs of the same class as TRE and/or RIO, or any of their excipients.
Planned treatment, or treatment, with another investigational drug within 1 month prior to randomization.
Recent (<6 months) hemoptysis and/or history of severe hemoptysis requiring intervention (bronchial artery embolization).
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Central trial contact
Valerie Boss, MS
Data sourced from clinicaltrials.gov
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