Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome

• Status: Recruiting
• Trial end date: 2026-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Collaborator: InCor Heart Institute
• Treatments: Pentoxifylline

Criteria

Inclusion Criteria:

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

2. Using or not oral anticoagulation with warfarin.

Exclusion Criteria:

1. Hospitalized.

2. History of relevant and/or repetitive bleeding.

3. Relevant comorbidities with specific treatments.

4. Systemic syndromes, except Down syndrome.

5. Candidates for surgical treatment of any nature, except dental.

6. Clinically manifest systemic infectious or inflammatory disease.

7. Thrombocytopenia (<80x10*9 platelets/L).

8. Patients in chronic anticoagulation regimen other than warfarin.

9. Diabetics individuals.

10. Pregnancy in progress, interruption of contraception or amenorrhea.

11. History of intolerance of pentoxifylline or other xanthine derivatives.

12. "Creatinine clearance" less than or equal to 30 mL/minute.