Vasoreactivity Testing With Intravenous Sildenafil in Patients With Precapillary Pulmonary Hypertension (Treatment Optimisation Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- efficacy of Sildenafil I.V. for vasoreactivity testing
研究概览
简要总结
Sildenafil is a selective pulmonary vasodilator; in patients with a special kind of pulmonary hypertension it is approved for treatment. The trial seeks to find out, whether the acute response to this treatment (= vasoreactivity testing) given intravenously is effective and allows prediction of therapy success during a following oral treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Precapillary pulmonary hypertension associated with connective tissue disease
- •resting mean pressure in the pulmonary artery of > 24 mmHg
- •resting mean pulmonary capillary wedge pressure (PCWP) of < 16 mmHg
- •age 18 to 80 years
- •women of childbearing potential must have a negative pregnancy test (ß-HCG in urine) and must use effective methods of contraception
- •women must not be breastfeeding
- •ability to understand and sign the informed consent, correctly signed informed consent
排除标准
- •pretreatment with Sildenafil
- •contraindications for Sildenafil treatment:
- •known intolerance to Sildenafil,
- •optic neuropathy (NAION),
- •known hereditary retina disease,
- •need of nitrate therapy
- •advanced liver cirrhosis - CHILD C
- •severely reduced renal function with GFR < 30 ml/min/1,73 m²
- •stroke or myocardial infarction within the last 6 months
研究组 & 干预措施
Sildenafil
oral Sildenafil 20 mg three times a day for 90 days
干预措施: Sildenafil (Drug)
结局指标
主要结局
efficacy of Sildenafil I.V. for vasoreactivity testing
时间窗: 1.5 hours
Right heart catheterisation with comprehensive hemodynamic measurements (pressures in RA, RV, PA, PCW position; cardiac index (CI) by thermodilution; oxygen saturation in the PA; the same under exercise conditions) is performed. In case of precapillary pulmonary hypertension, Sildenafil is given I.V. and acute tolerability, safety and efficacy on hemodynamic parameters are registrated. Successful vasoreactivity testing is defined by lowering the mean PA pressure by 10 mmHg or more, lowering it below 40 mmHg and maintaining / rising of the CI. Safety is mainly defined by lack of a substantial effect of the study drug on systemic blood pressure.
次要结局
- clinical efficacy of sildenafil per os predicted by testing it intravenously in the course of oral therapy(90 days)
研究者
Dr. Andreas Rieth
Dr. med., senior physician cardiology
Kerckhoff Heart Center