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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT01072058 |
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Date of registration:
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18/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
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Scientific title:
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Prospective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01072058 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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Phase:
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Phase 4
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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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Eloisa S.D.O. Bonfá, 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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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of Rheumatoid Arthritis eligible to receive TNF blockers
- Diagnosis of Ankylosing Spondylitis eligible to receive TNF blockers
Exclusion Criteria:
- Clinical heart failure
- Chagas'disease
- Stable or unstable angina
- Past history of myocardial infarct
- Systemic árterial hypertension (grade 3)
- Valvulopathy
- Chronic kidney disease
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Spondylitis, Ankylosing
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Intervention(s)
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Drug: TNF blockers (infliximab, adalimumab, etanercept)
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Primary Outcome(s)
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Development, deterioration ou improvement of subclinical heart dysfunction
[Time Frame: 0, 6 ,12, 18 and 24 months]
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Secondary ID(s)
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CapPesq1252/07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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