EUCTR2008-008135-28-GB进行中(未招募)不适用
Effect of Sildenafil on Pulmonary Artery Pressure during hypoxia and exercise in Chronic Heart Failure - Effect of sildenafil on PA pressure during exercise and hypoxia in CHF
Hull and East Yorkshire NHS Hospitals Trust0 个研究点开始时间: 2009年4月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Stable heart failure.
- •- LVEF <40% or NT-proBNP >600pg/ml.
- •- Tricuspid Regurgitation velocity must be measurable reliably by echocardiography to estimate the pulmonary artery systolic.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Primary valve disease.
- •- Oxygen saturation of <90% on air at rest (severe pulmonary disease) in whom a normal hypoxiama state could not be assessed.
- •- Patients with severe tricuspid regurgitation, in whom pulmonary artery pressure may be underestimated.
- •- Arrhythmias precluding accurate measurement by echocardiography.
- •- Patients with severe optic neuropathy (non-arteritic anterior ischemic optic neuropathy (NAION).
- •- Patients prescribed long-acting nitrates within the previous 24 hours or short-acting agents within 6 hours(Interaction with sildenafil).
- •- Patients with ritonavir treatment (ritonavir is protease inhibitor with a highly potent CYP3A4)(Interaction with sildenafil).
- •- Patients receiving inducers such as barbiturates, carbamazepine, phenytoin, efavirenz, nevirapine, rifampin,rifabutin (CYP3A4 inductors) will be excluded as patients receiving ketoconazole, itraconazole, ritonavir (CYP3A4 inhibitors).
- •- Patients prescribed a sildenafil derivative within 24h time period before study procedures are followed.
- •- Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
- •- Patients with coronary artery disease causing unstable angina.
- •- Patients with hypertension (BP >170/110).
- •- Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
- •- Patients currently on bosentan therapy.
- •- Patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease) or in patients who have conditions, which may predispose them to priapism (such as sickle cell anemia, multiple myeloma or leukemia).
- •- Pregnant woman
研究者
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