Chagas Heart Disease Clinical Trial
Official 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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)