RecruitingNot ApplicableNCT05611268

Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome

Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome: a Randomized Study


Sponsor

University of Sao Paulo General Hospital

Enrollment

48 participants

Start Date

Jun 3, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 10 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests pentoxifylline — a drug that improves blood flow — as an add-on treatment for people with Eisenmenger syndrome, a serious complication of congenital heart disease where abnormal blood flow in the heart has led to severe pulmonary hypertension. **You may be eligible if...** - You have been diagnosed with Eisenmenger syndrome - Your functional class is WHO II, III, or IV for pulmonary hypertension - You may or may not be on anticoagulation (blood thinners like warfarin) **You may NOT be eligible if...** - You are currently hospitalized - You have a history of significant or repeated bleeding - You have major serious conditions requiring specific treatments - You are a candidate for any surgery (other than dental) - You have active systemic infection or inflammatory disease - You have low platelet counts (thrombocytopenia) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPentoxifylline

Oral Pentoxifylline 400 mg/day for 30 days, followed by 800 mg/day for 150 days


Locations(1)

Antonio Augusto Barbosa Lopes

São Paulo, Brazil

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05611268


Related Trials