Actively Recruiting
Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome
Led by University of Sao Paulo General Hospital · Updated on 2023-12-15
48
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo General Hospital
Lead Sponsor
I
InCor Heart Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eisenmenger syndrome in functional class II, III, or IV (World Health Organization for Pulmonary Hypertension)
- Adults aged 10 to 80 years
- Using or not using oral anticoagulation with warfarin
You will not qualify if you...
- Hospitalized patients
- History of relevant and/or repetitive bleeding
- Presence of relevant comorbidities requiring specific treatments
- Systemic syndromes except Down syndrome
- Candidates for surgical treatment of any kind except dental
- Clinically manifest systemic infectious or inflammatory disease
- Thrombocytopenia (platelet count less than 80x10⁹/L)
- Use of chronic anticoagulation other than warfarin
- Diabetes mellitus
- Pregnancy, interruption of contraception, or amenorrhea
- History of intolerance to pentoxifylline or other xanthine derivatives
- Creatinine clearance less than or equal to 30 mL/minute
AI-Screening
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Trial Site Locations
Total: 1 location
1
Antonio Augusto Barbosa Lopes
São Paulo, Brazil
Actively Recruiting
Research Team
A
Antonio Augusto Barbosa Lopes, MD
CONTACT
M
Mariana Cappelletti Galante, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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