Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-80
SponsorUniversity of Sao Paulo General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Eisenmenger syndrome in functional class II, III or IV (World Health Organization for Pulmonary Hypertension).

Using or not oral anticoagulation with warfarin.

Disqualifiers

Hospitalized.

History of relevant and/or repetitive bleeding.

Relevant comorbidities with specific treatments.

Systemic syndromes, except Down syndrome.

Trial design

Treatments tested in this trial

  • Pentoxifylline

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators