NCT01072058Unknown4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Development, deterioration ou improvement of subclinical heart dysfunction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Rheumatoid Arthritis eligible to receive TNF blockers
- •Diagnosis of Ankylosing Spondylitis eligible to receive TNF blockers
排除标准
- •Clinical heart failure
- •Chagas'disease
- •Stable or unstable angina
- •Past history of myocardial infarct
- •Systemic árterial hypertension (grade 3)
- •Valvulopathy
- •Chronic kidney disease
研究组 & 干预措施
TNF blockers
Other
干预措施: TNF blockers (infliximab, adalimumab, etanercept) (Drug)
结局指标
主要结局
Development, deterioration ou improvement of subclinical heart dysfunction
时间窗: 0, 6 ,12, 18 and 24 months
次要结局
未报告次要终点
研究者
Julio Moraes, MD
MD
University of Sao Paulo
研究点 (1)
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