NCT01072058
Unknown
Phase 4
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
InterventionsTNF blockers (infliximab, adalimumab, etanercept)
Overview
- Phase
- Phase 4
- Intervention
- TNF blockers (infliximab, adalimumab, etanercept)
- Conditions
- Arthritis, Rheumatoid
- Sponsor
- University of Sao Paulo
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Development, deterioration ou improvement of subclinical heart dysfunction
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to determine possible alterations in cardiac function in patients with Rheumatoid Arthritis and Ankylosing Spondylitis under anti-TNF therapy, without clinical heart disfunction at baseline, using highly sensitive non-invasive methods.
Investigators
Julio Moraes, MD
MD
University of Sao Paulo
Eligibility 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 árterial hypertension (grade 3)
- •Valvulopathy
- •Chronic kidney disease
Arms & Interventions
TNF blockers
Intervention: TNF blockers (infliximab, adalimumab, etanercept)
Outcomes
Primary Outcomes
Development, deterioration ou improvement of subclinical heart dysfunction
Time Frame: 0, 6 ,12, 18 and 24 months
Study Sites (1)
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