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

NCT ID: NCT01072058

Last Updated: 2013-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29

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.

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

TNF blockers

Group Type: OTHER

TNF blockers (infliximab, adalimumab, etanercept)

Intervention Type: DRUG

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 .

Interventions

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 .

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Julio Moraes, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eloisa S.D.O. Bonfá, MD, PhD

Role: STUDY_DIRECTOR

Locations

Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CapPesq1252/07

Identifier Type: -

Identifier Source: org_study_id