Using Pentoxifylline to Help Patients With Eisenmenger Syndrome
Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome: a Randomized Study
This study is testing if a medication called pentoxifylline can help people with Eisenmenger syndrome feel better by improving their blood flow and reducing inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 10 Years to 80 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT05611268 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of chronic oral administration of pentoxifylline in patients with Eisenmenger syndrome, a severe form of pulmonary arterial hypertension linked to congenital heart disease. The research aims to determine whether pentoxifylline can increase levels of thrombomodulin, a protein that has anticoagulant and anti-inflammatory properties. The study includes patients in functional classes II, III, or IV, and evaluates the potential of pentoxifylline to improve their condition by reducing blood viscosity and enhancing erythrocyte deformability. Participants may or may not be using warfarin for anticoagulation.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with Eisenmenger syndrome in functional class II, III, or IV.
Not a fit: Patients with significant comorbidities, those hospitalized, or individuals with a history of bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing thrombotic complications in patients with Eisenmenger syndrome.
How similar studies have performed: While the use of pentoxifylline in this context is novel, other studies have explored its effects on blood viscosity and thrombotic conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Eisenmenger syndrome in functional class II, III or IV (World Health Organization for Pulmonary Hypertension). 2. Using or not oral anticoagulation with warfarin. Exclusion Criteria: 1. Hospitalized. 2. History of relevant and/or repetitive bleeding. 3. Relevant comorbidities with specific treatments. 4. Systemic syndromes, except Down syndrome. 5. Candidates for surgical treatment of any nature, except dental. 6. Clinically manifest systemic infectious or inflammatory disease. 7. Thrombocytopenia (\<80x10\*9 platelets/L). 8. Patients in chronic anticoagulation regimen other than warfarin. 9. Diabetics individuals. 10. Pregnancy in progress, interruption of contraception or amenorrhea. 11. History of intolerance of pentoxifylline or other xanthine derivatives. 12. "Creatinine clearance" less than or equal to 30 mL/minute.
Where this trial is running
São Paulo
- Antonio Augusto Barbosa Lopes — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Antonio Augusto Barbosa Lopes, MD — InCor Heart Institute
- Study coordinator: Antonio Augusto Barbosa Lopes, MD
- Email: aablopes@usp.br
- Phone: +55 11 2661-5409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.