Overview

This trial is active, not recruiting.

Conditions arthritis, rheumatoid, spondylitis, ankylosing
Treatment tnf blockers (infliximab, adalimumab, etanercept)
Phase phase 4
Sponsor University of Sao Paulo
Start date February 2008
End date February 2011
Trial size 100 participants
Trial identifier NCT01072058, CapPesq1252/07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose screening
Arm
(Other)
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 .

Primary Outcomes

Measure
Development, deterioration ou improvement of subclinical heart dysfunction
time frame: 0, 6 ,12, 18 and 24 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by University of Sao Paulo.