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

The recruitment status of this study is unknown because the information has not been verified recently.

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

Sponsor:

Information provided by (Responsible Party):

Julio Moraes, MD, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01072058

First received: February 18, 2010

Last updated: June 5, 2013

Last verified: June 2013

History of Changes

Purpose

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:

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

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 .

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 .

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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:


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

ClinicalTrials.gov processed this record on September 27, 2016

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