The Eisenmenger syndrome corresponds to the most advanced form of pulmonary arterial hypertension associated with congenital heart disease. The syndrome causes chronic hypoxemia, with an increase in erythrocyte mass, which predisposes to thrombotic complications. Pentoxifylline is a xanthine derivative and it is considered as a hemorrheological agent with described effects of reduction in erythrocyte and platelet aggregation, adhesion and activation of leukocytes, and endothelial damage. The main objective of this study is to verify if the chronic oral administration of pentoxifylline to Eisenmenger patients induces an increase in the circulating levels of thrombomodulin, a naturally occurring proteoglycan with anticoagulant, anti thrombotic and anti-inflammatory properties.
Eisenmenger syndrome in functional class II, III or IV (World Health Organization for Pulmonary Hypertension).
Using or not oral anticoagulation with warfarin.
Hospitalized.
History of relevant and/or repetitive bleeding.
Relevant comorbidities with specific treatments.
Systemic syndromes, except Down syndrome.
Factorial
Pentoxifylline
DrugOral Pentoxifylline 400 mg/day for 30 days, followed by 800 mg/day for 150 days
Plasma concentration of Thrombomodulin
Change in plasma concentration of thrombomoduin at 3 months and 6 months of pentoxifylline therapy compared to baseline.
Plasma concentration of tissue factor
Change in plasma concentration of tissue factor at 3 months and 6 months of pentoxifylline therapy compared to baseline.
Monocyte thrombomodulin content
Change in mean fluorescence intensity (MFI) for thrombomodulin in circulating (blood) monocytes measured by flow cytometry 3 months and 6 months of pentoxifylline therapy compared to baseline.
Monocyte tissue factor content
Change in mean fluorescence intensity (MFI) for tissue factor in circulating (blood) monocytes measured by flow cytometry 3 months and 6 months of pentoxifylline therapy compared to baseline.
Plasma concentration of other markers of thrombosis
Change in plasma concentration of D-dimer and thrombin-antithrombin complexes at 3 months and 6 months of pentoxifylline therapy compared to baseline.
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University of Sao Paulo General Hospital
Lead sponsor
InCor Heart Institute
Collaborator
