Study of Pentoxifylline Added to Routine Treatment for Eisenmenger Syndrome in Patients Aged 10 to 80 Years

What this Trial Is About

Researchers are studying Eisenmenger syndrome, the most advanced form of pulmonary arterial hypertension linked to congenital heart disease. This condition causes chronic low oxygen levels and increased red blood cells, which raises the risk of blood clots. The study aims to see if taking pentoxifylline, a drug that may reduce blood cell clumping and inflammation, raises levels of thrombomodulin, a natural protein that helps prevent clotting and inflammation in these patients. This is a prospective, single-center, randomized study including 48 adults with Eisenmenger syndrome already on standard treatments for pulmonary arterial hypertension. Participants are randomly assigned to either continue their routine therapy or receive pentoxifylline alongside their usual treatment. Pentoxifylline is taken orally at 400 mg per day for the first 30 days, then increased to 800 mg per day for the next five months, completing a six-month treatment period. During the study, researchers will measure blood levels of thrombomodulin and other clotting markers at 3 and 6 months. They will also assess changes in monocyte proteins related to clotting, physical capacity, oxygen levels, blood counts, and heart function. The study will monitor clinical events and safety throughout. All participants maintain their regular pulmonary arterial hypertension treatment during the trial, which is planned to end in September 2026.

Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome