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Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome

NCT05611268 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-12-15

No results posted yet for this study

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.

Conditions

  • Eisenmenger Syndrome

Interventions

DRUG

Pentoxifylline

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

Sponsors & Collaborators

  • InCor Heart Institute

    collaborator OTHER

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Antonio Augusto Barbosa Lopes, MD · InCor Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
10 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-03
Primary Completion
2024-09-30
Completion
2026-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05611268 on ClinicalTrials.gov