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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.
Last refreshed on: 19 February 2015
Main ID:  NCT01072058
Date of registration: 18/02/2010
Prospective Registration: No
Primary sponsor: University of Sao Paulo
Public title: Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
Scientific title: 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
Date of first enrolment: February 2008
Target sample size: 100
Recruitment status: Active, not recruiting
Study type:  Interventional
Study design:  Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening  
Phase:  Phase 4
Countries of recruitment
Name:     Eloisa S.D.O. Bonf√°, MD, PhD
Key inclusion & exclusion criteria

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 √°rterial hypertension (grade 3)

- Valvulopathy

- Chronic kidney disease

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Drug: TNF blockers (infliximab, adalimumab, etanercept)
Primary Outcome(s)
Development, deterioration ou improvement of subclinical heart dysfunction [Time Frame: 0, 6 ,12, 18 and 24 months]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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