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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
Sponsor:
Information provided by (Responsible Party):
Julio Moraes, MD, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE February 18, 2010
First Posted Date  ICMJE February 19, 2010
Last Update Posted Date June 7, 2013
Study Start Date  ICMJE February 2008
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
Development, deterioration ou improvement of subclinical heart dysfunction [ Time Frame: 0, 6 ,12, 18 and 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Arthritis, Rheumatoid
  • Spondylitis, Ankylosing
Intervention  ICMJE 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 .
Study Arms  ICMJE TNF blockers
Intervention: Drug: TNF blockers (infliximab, adalimumab, etanercept)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 18, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01072058
Other Study ID Numbers  ICMJE CapPesq1252/07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julio Moraes, MD, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eloisa S.D.O. Bonfá, MD, PhD
PRS Account University of Sao Paulo
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP