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

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ClinicalTrials.gov Identifier: NCT01072058

Recruitment Status : Unknown

Verified June 2013 by Julio Moraes, MD, University of Sao Paulo.
Recruitment status was: Active, not recruiting

First Posted : February 19, 2010

Last Update Posted : June 7, 2013

Sponsor:

Information provided by (Responsible Party):

Julio Moraes, MD, University of Sao Paulo

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 (Clinical Trial)
Estimated Enrollment :	100 participants
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 :	February 2008
Actual Primary Completion Date :	February 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Ankylosing spondylitis Rheumatoid arthritis

MedlinePlus related topics: Ankylosing Spondylitis Arthritis Rheumatoid Arthritis

Drug Information available for: Infliximab Etanercept Adalimumab

Genetic and Rare Diseases Information Center resources: Spondylarthropathy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

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 .

Outcome Measures

Primary Outcome Measures :

Development, deterioration ou improvement of subclinical heart dysfunction [ Time Frame: 0, 6 ,12, 18 and 24 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072058

Locations


Brazil
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo
Sao Paulo, Brazil

Sponsors and Collaborators

University of Sao Paulo

Investigators


Study Director:	Eloisa S.D.O. Bonfá, MD, PhD

More Information


Responsible Party:	Julio Moraes, MD, MD, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01072058 History of Changes
Other Study ID Numbers:	CapPesq1252/07
First Posted:	February 19, 2010 Key Record Dates
Last Update Posted:	June 7, 2013
Last Verified:	June 2013

Keywords provided by Julio Moraes, MD, University of Sao Paulo:


Infliximab Adalimumab Etanercept Heart failure Diastolic disfunction TNF blocker	Anti-TNF Echocardiography Tissue doppler imaging Brain Natriuretic Peptide NT-proBNP

Additional relevant MeSH terms:


Arthritis Arthritis, Rheumatoid Spondylitis Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Bone Diseases Spinal Diseases Spondylarthropathies	Spondylarthritis Ankylosis Adalimumab Etanercept Infliximab Natriuretic Peptide, Brain Anti-Inflammatory Agents Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents

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