JPRN-UMIN000019549已完成未知
Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension - Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension (MR BPA study)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 61
研究概览
简要总结
By month 12, the mean PAP improved by -16.3+/-1.6mmHg in the BPA group, and -7.0+/-1.5mmHg in the riociguat group (group difference, -9.3 mmHg; 95% confidence interval -12.7 - -5.9, p<0.001). BPA group also demonstrated significant improvements in SaO2, PaO2, EQ-5D-3L, and functional class, whereas the cardiac output improved significantly in the riociguat group. The BPA related complication rate was 11.6%.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients meeting any of the following exclusion criteria will be excluded from the trial. (a) patients with a history of BPA. (b) patients who underwent PEA within six months prior to consent acquisition. (c) patients who are using unapproved pharmaceutical products. (d) patients who used a pulmonary vasodilator within four weeks prior to the right heart catheterization after consent acquisition. (e) patients with co-existing etiology of pulmonary hypertension other than Group 4 in the Nice Pulmonary Hypertension Classification System. (f) patients who are pregnant or breastfeeding. (g) patients who met the contraindication for riociguat. (h) patients whose life expectancy is less than two years. (i) patients who are considered to be unsuitable for participation by investigators.
研究者
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