Acute Effects of Benzbromaron on the Pulmonary Circulation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pulmonary vascular resistance (Wood units) assessed by right heart catheterization
研究概览
简要总结
Actual studies suggest that a calcium activated chlorid channel (TMEM16A) may play a relevant role in the pathogenesis of pulmonary arterial hypertension (PAH). The inhibition of this channel led to pulmonary vasorelaxation in preclinical studies. Benzbromarone is a well known inhibitor of the TMEM16A channel and is used in patients with gout.
In this pilot study the investigators plan to investigate if Benzbromarone has an acute effect on the pulmonary arteries in humans. This will be investigated within the frame of a right heart catheterization performed in patients with known PAH due to clinical reasons. The investigators hypothesize that the application of Benzbromarone leads to pulmonary vasodilation, which can be recognized by the decrease in pulmonary vascular resistance. In addition, the change in pulmonary and systemic arterial pressure, pulmonary arterial wedge pressure, heart rate and arterial oxygen saturation will be assessed. Due to clinical reasons patients will receive NO (15 ppm) during right heart catheterization. Hemodynamic changes upon NO and Benzbromarone may be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •known pulmonary arterial hypertension
- •right heart catheterization indicated due to clinical reasons
排除标准
- •known allergy against Benzbromaron, Gelborange S or other ingredient of the used drug (Benzbromarone AL) or a drug with similar chemical structure
- •severe renal insufficiency (GFR<30ml/min/kg)
- •renal diathesis
- •severe hepatic disease (Bilirubin >1.6 mg% or AST or ALT > 3x Norm)
- •known pregnancy
- •uncontrolled systemic arterial hypertension (>150 mmHg systolic or 95 mmHg diastolic)
- •uncontrolled ventricular arrythmia
- •uncontrolled bradycardic or tachycardic supraventricular arrythmia
- •myocardiac infarction within the last 12 months
- •pulmonary embolism within the last 6 months
- •ongoing iv. or sc. Prostanoid therapy for PAH
- •Pulmonary hypertension other than PAH
研究组 & 干预措施
Benzbromarone
1x200mg Benzbromarone
干预措施: Benzbromarone (Drug)
结局指标
主要结局
Pulmonary vascular resistance (Wood units) assessed by right heart catheterization
时间窗: 2 hours
次要结局
- Mean pulmonary arterial pressure (mmHg) assessed by right heart catheterization(2 hours)
- Mean systemic arterial pressure (mmHg) assessed by sphygmomanometer(2 hours)
- arterial oxygen saturation 8%) assessed by arterial blood gas analysis(2 hours)