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New treatment option for Eisenmenger Syndrome
Official title Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome
ClinicalTrials.gov ID: NCT05611268
What this study is testing
What is Pentoxifylline?
Pentoxifylline is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for eisenmenger syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 80
You may be able to join if
- Eisenmenger syndrome in functional class II, III or IV (World Health Organization for Pulmonary Hypertension).
- Using or not oral anticoagulation with warfarin.
You likely can't join if
- 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.
See the full eligibility criteria
- Eisenmenger syndrome in functional class II, III or IV (World Health Organization for Pulmonary Hypertension).
- Using or not oral anticoagulation with warfarin.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.