Arthritis, Rheumatoid, Spondylitis, Ankylosing
Conditions
Keywords
Infliximab, Adalimumab, Etanercept, Heart failure, Diastolic disfunction, TNF blocker, Anti-TNF, Echocardiography, Tissue doppler imaging, Brain Natriuretic Peptide, NT-proBNP
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.
Interventions
DRUGTNF blockers (infliximab, adalimumab, etanercept)
Subjects enrolled, who were eligible to anti-TNF therapy, were evaluated by echocardiography (conventional and tissue doppler imaging)and biomarkers (NT-proBNP and troponin T)at baseline. Then, they were treated with adalimumab 40mg subcutaneously every 2 weeks or infliximab 3 or 5mg/Kg (0, 2 and 6 weeks and thereafter every 8 weeks)or etanercept 50mg subcutaneously every week. And they were re-evaluated with 6, 12, 18 and 24 months from first dose of the TNF blocker .
Sponsors
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development, deterioration ou improvement of subclinical heart dysfunction | 0, 6 ,12, 18 and 24 months |
Countries
Brazil
Outcome results
None listed