Clinical trial NCT01566617: Impact of the Pharmaceutical Care on the Quality of Life in Patients With Chagas Heart Disease
Official title: Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chagas Heart Disease
Lead sponsor: Evandro Chagas Institute of Clinical Research
Sponsor class: OTHER
Collaborators: name: Alejandro Marcel Hasslocher Moreno, MD MSc PhD student
name: Andrea Costa, MD PhD
name: Andrea Silvestre de Sousa, MD PhD
name: Luiz Henrique C. Sangenis, MD MSc PhD student
name: Marcelo Teixeira de Holanda, MD MSc PhD student
name: Mayara da Costa Chambela - MSc student
name: Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD
name: Roberto Magalhães Saraiva, MD PhD
name: Sergio Salles Xavier, MD PhD
First posted: 2012-03-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life.
timeFrame: 12 months
Secondary outcomes:
measure: Incidence and types of drug-related problems
timeFrame: 12 months
measure: Physical functional capacity.
timeFrame: 12 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Evandro Chagas Clinical Research Institute
Study officials:
affiliation: Evandro Chagas Clinical Research Institute
name: Gilberto M Silva, pharmaceutical
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sperandio da Silva GM, Chambela MC, Sousa AS, Sangenis LH, Xavier SS, Costa AR, Brasil PE, Hasslocher-Moreno AM, Saraiva RM. Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial. Trials. 2012 Dec 27;13:244. doi: 10.1186/1745-6215-13-244.