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

University of Sao Paulo

Status and phase: Unknown; Phase 4

Conditions: Spondylitis, Ankylosing; Arthritis, Rheumatoid

Treatments: Drug: TNF blockers (infliximab, adalimumab, etanercept)

Study type: Interventional

Funder types: Other

Identifiers

NCT01072058

CapPesq1252/07

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

TNF blockers

Other group

Treatment:

Drug: TNF blockers (infliximab, adalimumab, etanercept)