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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
Information provided by (Responsible Party):

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
Primary Completion Date : February 2011

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 .

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

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
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:
TNF blocker
Heart failure
Diastolic disfunction
Tissue doppler imaging
Brain Natriuretic Peptide

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases
Natriuretic Peptide, Brain
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents