Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Actelion
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Symptomatic (modified NYHA class III) iPAH or PAH-SSc·
PAH confirmed by right heart catheterization performed within 3 months before enrolment mPAP \> 25 mmHg, PCWP \< 15 mmHg and PVR \> 3 mmHg/l/min.
Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for 3 months after study treatment termination.
Bosentan naïve patients
You may not be if
Significant vasoreactivity during right heart catheterization defined as a fall in mPAP to \< 40 mmHg with a decrease \>= 10 mmHg and with a normal cardiac index (\>= 2.5 l/min.m2)· Severe obstructive lung disease: FEV1/FVC \< 0.5
Severe restrictive lung disease: TLC \< 0.7 of normal predicted value
Hemoglobin \<75% of the lower limit of the normal range· Systolic blood pressure \< 85 mmHg
Body weight \< 40 kg
Pregnancy or breast-feeding
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
Baseline aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) \> 3 times the upper limit of the normal (ULN) range.
Treatment for iPAH or PAH-SSc within 1 month before start of study treatment, excluding warfarin and acute administration of vasodilators for vascular reactivity testing during heart catheterization.
Treatment with epoprostenol or other prostacyclin analogs for iPAH or PAH-SSc within 1 month before start of study treatment
Treatment with glibenclamide (glyburide), fluconazole ketoconazole or ritonavir within 1 week before start of study treatment.
Current treatment with cyclosporine A or tacrolimus
Hypersensitivity to bosentan or any of the excipients of its formulation.
Patient who received an investigational drug (such as sildenafil) within 3 months before start of study treatment
Conditions that prevent compliance with the protocol or adherence to therapy.
Clareo Health | Pulmonary Artery Remodelling With Bosentan
