2025-523015-11-00招募中3 期
Bisoprolol for pericarditis -Phase III randomized controlled clinical trial in patients with acute or recurrent pericarditis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- The aim of this study is to evaluate the effectiveness of beta-blocking therapy with bisoprolol in reduce the persistence of pericarditis symptoms at 2 and 4 weeks and the frequency of relapses at 12 months
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of beta-blocking therapy with bisoprolol in reduce the persistence of pericarditis symptoms at 2 and 4 weeks and the frequency of relapses at 12 months.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •(1) acute or recurrent pericarditis of any aetiology within 48 hours of symptom onset, (2) age > 18 years, (3) informed consent and willingness to follow study procedures).
排除标准
- •(1) subacute presentation of pericarditis >48 hours after symptom onset, (2) age less than 18 years, (3) established pregnancy and lactation status, (4) resting HR less than 75bpm, (5) clinical contraindication to bisoprolol therapy.
结局指标
主要结局
The aim of this study is to evaluate the effectiveness of beta-blocking therapy with bisoprolol in reduce the persistence of pericarditis symptoms at 2 and 4 weeks and the frequency of relapses at 12 months
The aim of this study is to evaluate the effectiveness of beta-blocking therapy with bisoprolol in reduce the persistence of pericarditis symptoms at 2 and 4 weeks and the frequency of relapses at 12 months
次要结局
- Secondary endpoints: persistence of symptoms at 1 month. Frequency of relapses at 12 months. Additional secondary analysis: correlation between baseline C-reactive protein values and heart rate at first observation
研究者
SOC Cardiologia
Scientific
Azienda Sanitaria Universitaria Friuli Centrale
研究点 (5)
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