Actively Recruiting
Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome: a Randomized Study
Led by University of Sao Paulo General Hospital · Updated on 2023-12-15
48
Participants Needed
1
Research Sites
104 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
Researchers are studying Eisenmenger syndrome, the most advanced form of pulmonary arterial hypertension linked to congenital heart disease. This condition causes chronic low oxygen levels and increased red blood cells, which raises the risk of blood clots. The study aims to see if taking pentoxifylline, a drug that may reduce blood cell clumping and inflammation, raises levels of thrombomodulin, a natural protein that helps prevent clotting and inflammation in these patients. This is a prospective, single-center, randomized study including 48 adults with Eisenmenger syndrome already on standard treatments for pulmonary arterial hypertension. Participants are randomly assigned to either continue their routine therapy or receive pentoxifylline alongside their usual treatment. Pentoxifylline is taken orally at 400 mg per day for the first 30 days, then increased to 800 mg per day for the next five months, completing a six-month treatment period. During the study, researchers will measure blood levels of thrombomodulin and other clotting markers at 3 and 6 months. They will also assess changes in monocyte proteins related to clotting, physical capacity, oxygen levels, blood counts, and heart function. The study will monitor clinical events and safety throughout. All participants maintain their regular pulmonary arterial hypertension treatment during the trial, which is planned to end in September 2026.
CONDITIONS
Brief Title
Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Eisenmenger syndrome in functional class II, III, or IV according to World Health Organization for Pulmonary Hypertension
- Age between 10 and 80 years
- Using or not using oral anticoagulation with warfarin
- Able to participate in a randomized study as an adult patient
You will not qualify if you...
- Currently hospitalized
- History of significant or repeated bleeding
- Presence of relevant comorbidities requiring specific treatments
- Systemic syndromes except Down syndrome
- Candidates for surgical treatment other than dental procedures
- Active systemic infectious or inflammatory disease
- Thrombocytopenia with platelets less than 80x10^9/L
- Use of chronic anticoagulation other than warfarin
- Diabetes
- Current pregnancy, interruption of contraception, or amenorrhea
- History of intolerance to pentoxifylline or other xanthine derivatives
- Creatinine clearance less than or equal to 30 mL/min
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive oral pentoxifylline starting at 400 mg/day for 30 days, followed by 800 mg/day for 5 months as an adjunct to their routine pulmonary arterial hypertension treatment. Participants in the control group continue with routine treatment only.
Visits at 3 months and 6 months for assessments
Trial Site Locations
Total: 1 location
1
Antonio Augusto Barbosa Lopes
São Paulo, Brazil
Actively Recruiting
Research Team
A
Antonio Augusto Barbosa Lopes, MD
M
Mariana Cappelletti Galante, PharmD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here