Chagas disease
Conditions
Interventions
1. Intervention group: 23 patients who received 400 mg pentoxifylline every 8 hours for 6 months
2. Active Control Group: 23 patients receive 1 placebo tablet of the same value every 8 hours for 6 months
Drug
Sponsors
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The patients will be recruited from the population already attended at the specialized outpatient clinics of the Cardiology Center of the University of Ribeirão Preto Medical School Hospital das Clínicas. The study will include patients with a diagnosis of chronic chagasic heart disease confirmed by two distinct serological tests indirect immunofluorescence and enzyme immunoabsorption assay showing typical left ventricular segmental parietal mobility changes evidenced by transthoracic echocardiography that characterize chronic myocardial involvement by the disease. Study participants should have preserved left ventricular ejection fraction or with a slight reduction greater than 35%, may exhibit mild symptoms of heart failure
Exclusion criteria
Exclusion criteria: Patients with another etiology for myocardial dysfunction such as alcoholism will be excluded, previous myocardial infarction, known coronary artery disease, use of cardiotoxic or illicit drugs and peripartum cardiomyopathy, primary valvular heart disease and pericardial disease. Patients with comorbidities that compromise functional capacity such as severe chronic obstructive pulmonary disease will also be excluded; severe liver disease; collagenosis, untreated thyroid dysfunction. Coronary artery disease should be excluded by cardiac catheterization in those patients with ischemic perfusion defects on myocardial perfusion scintigraphy who exhibit 2 or more risk factors for atherosclerotic coronary artery disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected left ventricular ejection fraction increased by transthoracic echocardiography by at least 5% after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate improvement of quality of life scores through the SF36 questionnaire;Reduction of severity and extent of myocardial ischemia seen on myocardial perfusion scintigraphy;Reduction of 24-hour Holter ventricular arrhythmias;Reduction of serum levels of inflammatory interleukins after intervention | — |
Countries
Brazil
Contacts
Public ContactMarcus Simões
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed