Status:
RECRUITING
Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
InCor Heart Institute
Conditions:
Eisenmenger Syndrome
Eligibility:
All Genders
10-80 years
Phase:
NA
Brief 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 e...
Detailed Description
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 e...
Eligibility Criteria
Inclusion Criteria:
- Eisenmenger syndrome in functional class II, III or IV (World Health Organization for Pulmonary Hypertension).
- Using or not oral anticoagulation with warfarin.
Exclusion Criteria:
- Hospitalized.
- History of relevant and/or repetitive bleeding.
- Relevant comorbidities with specific treatments.
- Systemic syndromes, except Down syndrome.
- Candidates for surgical treatment of any nature, except dental.
- Clinically manifest systemic infectious or inflammatory disease.
- Thrombocytopenia (<80x10*9 platelets/L).
- Patients in chronic anticoagulation regimen other than warfarin.
- Diabetics individuals.
- Pregnancy in progress, interruption of contraception or amenorrhea.
- History of intolerance of pentoxifylline or other xanthine derivatives.
- "Creatinine clearance" less than or equal to 30 mL/minute.
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05611268
Start Date
June 3 2022
End Date
September 30 2026
Last Update
December 15 2023
Active Locations (1)
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1
Antonio Augusto Barbosa Lopes
São Paulo, Brazil