Chagas Heart Disease Clinical Trial
— ChagasCareOfficial title:
Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 88 |
| Est. completion date | March 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 76 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Evandro Chagas Clinical Research Institute | Rio de Janeiro |
| Lead Sponsor | Collaborator |
|---|---|
| Evandro Chagas Institute of Clinical Research | 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 |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of life. | 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. | 12 months | No |
| Secondary | Incidence and types of drug-related problems | To evaluate the drug-related problems based on the classi?cation 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. | 12 months | No |
| Secondary | Physical functional capacity. | 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. | 12 months | No |