Back to resultsHeart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
Primary Purpose
Arthritis, Rheumatoid, Spondylitis, Ankylosing
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
TNF blockers (infliximab, adalimumab, etanercept)
Sponsored by
About this trial
This is an interventional screening trial for Arthritis, Rheumatoid focused on measuring Infliximab, Adalimumab, Etanercept, Heart failure, Diastolic disfunction, TNF blocker, Anti-TNF, Echocardiography, Tissue doppler imaging, Brain Natriuretic Peptide, NT-proBNP
Eligibility 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
Sites / Locations
- Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
TNF blockers
Arm Description
Outcomes
Primary Outcome Measures
Development, deterioration ou improvement of subclinical heart dysfunction
Secondary Outcome Measures
Full Information
NCT ID
NCT01072058
First Posted
February 18, 2010
Last Updated
June 5, 2013
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01072058
Brief Title
Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
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 Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid, Spondylitis, Ankylosing
Keywords
Infliximab, Adalimumab, Etanercept, Heart failure, Diastolic disfunction, TNF blocker, Anti-TNF, Echocardiography, Tissue doppler imaging, Brain Natriuretic Peptide, NT-proBNP
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TNF blockers
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
TNF blockers (infliximab, adalimumab, etanercept)
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Development, deterioration ou improvement of subclinical heart dysfunction
Time Frame
0, 6 ,12, 18 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eloisa S.D.O. Bonfá, MD, PhD
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
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