Chagas Heart Disease
Conditions
Brief summary
The investigators hypothesize that pharmaceutical care may constitute an important tool for the clinical management of these patients by improving their compliance to their treatment with consequent improvement in their quality of life by minimizing symptoms, and decreasing the number of hospital admissions and adverse drug reactions. Therefore, the aim of this trial is to evaluate the contribution of pharmaceutical care to clinical treatment of patients with Chagas heart disease complicated by heart failure. Study Type: Interventional Study Design: A total of 88 patients will be randomly assigned into two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care. Both groups will be subjected to a follow-up period of 12 months. The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes include drug-related problems and exercise tolerance measured by the standard six-minute walk test.
Interventions
OTHERStandard care and Pharmaceutical care
Pharmaceutical care is the direct interaction between the pharmacist and the drug's users in order to improve the therapeutic compliance among outpatients and promote adequate pharmacotherapeutic follow-up.
OTHERStandard care
These patients will only receive standard care, with out follow-up by the pharmacist
Sponsors
Alejandro Marcel Hasslocher Moreno, MD MSc PhD student
Andrea Costa, MD PhD
Andrea Silvestre de Sousa, MD PhD
Luiz Henrique C. Sangenis, MD MSc PhD student
Marcelo Teixeira de Holanda, MD MSc PhD student
Mayara da Costa Chambela - MSc student
Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD
Roberto Magalhães Saraiva, MD PhD
Sergio Salles Xavier, MD PhD
Evandro Chagas Institute of Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
* The proposed clinical trial will be conducted in volunteers with Chagas disease complicated by heart failure. * Subjects will include adults, men and women, racial or ethnic minorities. * Diagnosed by two distinct Chagas serology tests (indirect immunofluorescence and enzyme linked immunosorbent assay
Exclusion criteria
* Patients with any of comorbidities that significantly affect the cardiac performance, such as coronary artery disease, moderate or severe heart valvular disease, left ventricular (LV) hypertrophy, congenital heart disease, or that limit their survival, such as malignant tumors and HIV, will be excluded from the study. * Patients will be also be excluded in case of failure to give informed consent, inability to perform 6 minute- walk test, significant cognitive impairment, or pregnancy. * Individuals who are participating in others intervention trials will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life. | 12 months | The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Evaluation of patient quality of life during follow up of two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and types of drug-related problems | 12 months | To evaluate the drug-related problems based on the classification of the Brazilian Pharmaceutical Care Consensus. Evaluation of drug-related problems during follow up of two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care. |
| Physical functional capacity. | 12 months | All patients will have their physical functional capacity measured by the 6 minute-walk test (The patients will split in two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care). The test will be performed at the beginning of protocol and after 12 months of follow-up. |
Countries
Brazil
Contacts
Primary ContactMayara C Chambela, pharmaceutics
Backup ContactGilberto M Silva
Outcome results
None listed