Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01072058

Collaborator

(none)

100

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid Spondylitis, Ankylosing	Drug: TNF blockers (infliximab, adalimumab, etanercept)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official 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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: TNF blockers	Drug: TNF 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 .

Arm

Intervention/Treatment

Other: TNF blockers

Drug: TNF 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 .