Chagas' disease (chronic) with heart involvement
Conditions
Interventions
Initially all patients, regardless of which group they belonged, according to the degree of cardiac involvement (Ia, Ib, II and III) received carvedilol 12.5 mg three times daily for six months, orall
drug
dietary supplement
VS2.002.001.011
Sponsors
Universidade Federal do Rio de Janeiro
Universidade Federal de Santa Catarina
Eligibility
Age
21 Years to 70 Years
Inclusion criteria
Inclusion criteria: We included only patients who had previously studied the oxidative stress in the year 2003 onwards, aged between 21 and 70 years active and regularly monitored in ambulatory Chagas Service of Cardiology HUCFF diagnosed with Chagas disease, and that maintained the same eating habits. We only included patients with Chagas disease without other chronic diseases, apart from an endemic area for over 20 years.
Exclusion criteria
Exclusion criteria: Patients were excluded from the study if they had any of the following characteristics: Patients who have not completed the initial protocol of admission; Patients previously treated with carvedilol; Patients who were treated specifically for Chagas' disease; Patients with clinical or laboratory findings suggestive of severe liver or kidney disease or thyroid dysfunction; Patients with a history of chronic obstructive pulmonary disease (all forms), chronic alcoholism or smoking; Patients with anemia, obesity, hypertensive heart disease, diabetes mellitus or other systemic disease; Patients with signs, symptoms or a history of ischemic heart disease confirmed after investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Check the isolated effect of carvedilol for 6 months and the effect of combined therapy with antioxidant vitamin supplementation after 6 months, the blood of patients with chronic Chagas heart disease in different evolutionary stages.For this clinical evaluation was performed to allow verification of signs and cardiovascular and digestive symptoms consistent with Chagas disease, as well as for making a differential diagnosis with other cardiac or noncardiac disease that could affect the cardiovascular system. As patients were included in this study, they made over a period of one week a laboratory evaluation including complete blood count, glucose, urea and creatinine, uric acid, total cholesterol, LDL, HDL, triglycerides, sodium, calcium and potassium, total proteins and fractions, liver function tests and thyroid, examination of stools and urine analysis for abnormal elements and sediment. These tests were performed throughout this study when clinically required. The first 30 days after inclusion were performed the following tests: the conventional resting ECG with 12 leads, chest x-ray postero-anterior and lateral, one and two dimensional echocardiography and Doppler study of oxidative stress.Similarly, throughout the study, these tests were repeated annually and when they were needed, that is, with the patient's clinical change, except the study of oxidative stress was always performed after the intervention occurred. Antioxidant defenses and oxidative stress biomarkers were measured in the study three times in their respective groups, one before surgery and 2 after carvedilol administration of carvedilol (six months) and then after joint administration of carvedilol with vitamin E and C for another 6 months (carvedilol 12.5 mg, 3 times daily for 6 months, at a dose of 800UI/day vitamin E and 500mg/day vitamin C, single dose for 6 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical tests performed to test the antioxidant capacity of the drug carvedilol with / without vitamins E and C were the following: determining the activity of the following antioxidant enzymes: superoxide dismutase, catalase, glutathione peroxidase, glutathione S-transferase and glutathione reductase. Were also carried out determination of nonenzymatic antioxidants such as determining levels of reduced glutathione and vitamin E concentration in the blood of patients with chronic Chagas' disease before and after administration of carvedilol for 6 months and after this drug combination with vitamins E and C for over 6 months. Similarly we evaluated the lipid markers of damage, level of substances that react with thiobarbituric acid and protein damage, by determining the protein carbonyl content. We also analyzed the inflammatory markers such as nitric oxide levels and activity of the enzyme adenosine deaminase and myeloperoxidase. | — |
Countries
Brazil
Contacts
Public ContactRoberto Pedrosa
Universidade Federal do Rio de Janeiro
Outcome results
None listed