Randomized Pilot Trial of Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pulmonary vascular resistance
研究概览
简要总结
The study evaluates the technique of non-drug treatment of residual pulmonary hypertension in patients with chronic thromboembolic pulmonary hypertension after pulmonary thromboendarterectomy.
详细描述
The best strategy of treatment patients with chronic thromboembolic pulmonary hypertension is pulmonary thromboendarterectomy. In 5-30% of cases after pulmonary thromboendarterectomy residual pulmonary hypertension is persisted. The technique of radiofrequency pulmonary artery denervation in patients with idiopathic pulmonary arterial hypertension (type I) is known and was assessed during clinical investigation. In this study radiofrequency pulmonary artery denervation technique may be applied in patients with residual pulmonary hypertension after pulmonary thromboendarterectomy (type IV)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of residual pulmonary hypertension in patients after pulmonary thromboendarterectomy according to right heart catheterization: mean pulmonary artery pressure > 25 mm Hg or pulmonary vascular resistance > 400 dyn x sec x cm-5
排除标准
- •no evidence of residual pulmonary hypertension in patients after pulmonary thromboendarterectomy (mean pulmonary artery pressure <25 m Hg).
- •refusal of a patient to participate in the study.
- •the presence of severe concomitant diseases of the cardiovascular system and lungs, leading to pulmonary hypertension
- •the presence of other severe comorbidities that may result in death within a year.
结局指标
主要结局
Pulmonary vascular resistance
时间窗: 12 months
Units - (dyn x sec x cm-5)
次要结局
- 6-minute walking distance test(12 months)
- Echocardiographical sings of right ventricle function - 1(12 months)
- Echocardiographical sings of right ventricle function - 2(12 months)
- Pulmonary artery pressure(12 months)
研究者
Alexander Edemskiy
Principal investigator Alexander Edemskiy
Novosibirsk Scientific Research Institute for Circulatory Pathology