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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Julio Moraes, MD, University of Sao Paulo
ClinicalTrials.gov Identifier:
First received: February 18, 2010
Last updated: June 5, 2013
Last verified: June 2013

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 Intervention Phase
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Drug: TNF blockers (infliximab, adalimumab, etanercept)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Development, deterioration ou improvement of subclinical heart dysfunction [ Time Frame: 0, 6 ,12, 18 and 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2008
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 .


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Julio Moraes, MD, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01072058     History of Changes
Other Study ID Numbers: CapPesq1252/07
Study First Received: February 18, 2010
Last Updated: June 5, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Heart failure
Diastolic disfunction
TNF blocker
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
TNFR-Fc fusion protein
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents

ClinicalTrials.gov processed this record on April 17, 2014