Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome

NCT05611268 | Recruiting DMC

• 1 other identifier: CAAE 57562322.5.0000.0068
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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

Eisenmenger Syndrome

Keywords

Pulmonary Hypertension; Congenital Heart Disease; Thrombosis; Pentoxifylline; Thrombomodulin; Tissue Factor

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of Thrombomodulin

  Change in plasma concentration of thrombomoduin at 3 months and 6 months of pentoxifylline therapy compared to baseline.

  3 months and 6 months

Secondary Outcomes (4)

• Plasma concentration of tissue factor

  3 months and 6 months

• Monocyte thrombomodulin content

  3 months and 6 months

• Monocyte tissue factor content

  3 months and 6 months

• Plasma concentration of other markers of thrombosis

  3 months and 6 months

Study Arms (2)

No treatment group

NO INTERVENTION

24 patients that will continue receiving routine treatment for PAH

Pentoxifylline

OTHER

24 patients that will receive pentoxifylline and the routine treatment for PAH

Drug: Pentoxifylline

Interventions

Pentoxifylline DRUG

Oral Pentoxifylline 400 mg/day for 30 days, followed by 800 mg/day for 150 days

Pentoxifylline

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eisenmenger syndrome in functional class II, III or IV (World Health Organization for Pulmonary Hypertension).
• Using or not oral anticoagulation with warfarin.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• InCor Heart Institute: collaborator

Study Sites (1)

Antonio Augusto Barbosa Lopes

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Eisenmenger Complex; Hypertension, Pulmonary; Heart Defects, Congenital; Thrombosis

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Antonio Augusto Barbosa Lopes, MD

  InCor Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Augusto Barbosa Lopes, MD

CONTACT

+55 11 2661-5409; aablopes@usp.br

Mariana Cappelletti Galante, PharmD

CONTACT

+55112661-5709; Mariana.galante@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The professional responsible for obtainment of laboratory data including outcome measures will not have access to any clinical data or patient allocation to the study groups.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: November 10, 2022
• Study Start: June 3, 2022
• Primary Completion: September 30, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)