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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01006473 |
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Date of registration:
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01/11/2009 |
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Primary sponsor: |
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Public title:
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Exercise Training in Chagas Cardiomyopathy
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Scientific title:
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A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01006473 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Manoel Otávio C Rocha, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University if Minas Gerais |
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Name:
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Antonio L Ribeiro, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Minas Gerais |
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Name:
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Maria do Carmo P Nunes, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Minas Gerais |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Chronic Chagas dilated cardiomyopathy, defined by the echocardiography finding of a
dilated left ventricle with moderate or severe impaired left ventricular systolic
function (left ventricular ejection fraction = 45%).
- To be clinically stable for at least 3 months
- To have sinus rhythm
- To be under standard medical therapy use at the time.
Exclusion Criteria:
- Inability to attend regular exercise training
- The presence of a pacemaker, associated cardiac or systemic diseases
- Practitioners of regular physical activity
Age minimum:
30 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiomyopathy
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Chagas Disease
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Exercise Training
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Intervention(s)
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Other: Exercise training
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Procedure: Control
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Primary Outcome(s)
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BNP levels
[Time Frame: 12 weeks]
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Functional capacity
[Time Frame: 12 weeks]
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Functional class
[Time Frame: 12 weeks]
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Health related quality of life
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Complications related to the exercise training
[Time Frame: 12 weeks]
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Secondary ID(s)
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CNPq402024/2005-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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