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NCT01072058 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01072058
Other study ID # CapPesq1252/07
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received February 18, 2010
Last updated June 5, 2013
Start date February 2008

Study information
Verified date June 2013
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

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 .

Locations
Country Name City State
Brazil Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development, deterioration ou improvement of subclinical heart dysfunction 0, 6 ,12, 18 and 24 months Yes
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