Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Six minute walking distance
研究概览
简要总结
Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in constriction and high pressures. Treatment is given with a variety of drugs including the prostanoid class (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors (e.g. sildenafil).
Although these drugs are known to be effective alone, little is known about combining them together in various combinations.
In this trial we will add a long-acting PDE-5 inhibitor to the treatment of patients with pulmonary arterial hypertension who currently are receiving only a prostanoid drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 3 years of study enrollment): Mean PAP >25mmHg at rest or >30mmHg with exercise, by a PCWP< 15mmHg and by PVR >3 Wood Units.
- •Currently stable for at least 3 months on prostanoid monotherapy (epoprostenol iv or iloprost inhaled).
- •Willing and able to participate in all study follow-up procedures.
- •New York Heart Association (NYHA) Class II-IV.
- •Six minute walking distance between 100-450 meters at the baseline assessment.
- •Women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.
- •Patients with congenital heart disease are eligible for inclusion.
排除标准
- •Functional Class NYHA Class I.
- •PAH due to chronic pulmonary thromboembolic disease, left heart disease, chronic lung diseases (VC or FEV1 < 60% of predicted) or chronic hypoxia.
- •Acute intercurrent illness requiring hospital admission in the month proceeding screening.
- •Any non-PAH medical condition likely to interfere with participation in evaluation of study endpoints, e.g. musculoskeletal disorders.
- •Any uncontrolled or terminal non-PAH medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
- •Concomitant therapy with drugs known to interact adversely with the study drug.
- •Chronic renal failure - creatinine clearance <50ml/min as calculated with the Cockcroft equation.
- •Current participation in another clinical trial.
- •Pregnancy or planned pregnancy during the study period.
研究组 & 干预措施
1
Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis).
干预措施: Tadalafil (Drug)
2
Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra)
干预措施: Vardenafil (Drug)
结局指标
主要结局
Six minute walking distance
时间窗: 12 weeks
Level of pro-NT BNP
时间窗: 12 weeks
次要结局
- Echo-derived parameters(12 weeks)
- Cardiopulmonary exercise test(12 weeks)