PDE5-Inhibition With Sildenafil Reverses Exercise Oscillatory Breathing in Chronic Heart Failure: a Long-Term Cardiopulmonary Exercise Testing Placebo-Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Drug Effect on Oscillatory Breathing during Exercise
研究概览
简要总结
Exercise oscillatory breathing (EOB) is a ventilatory abnormality that occurs in approximately 20% of heart failure (HF) patients and carries a very unfavourable prognosis.
Pathophysiology seems quite complex and putative mechanisms include increased pulmonary capillary pressure and pulmonary vasoconstriction, circulatory blood-flow fluctuations in the pulmonary arterial system and instability of ventilatory control.
Inhibition of the phosphodiesterase 5 (PDE5) isoenzyme favourably regulates pulmonary vascular tone and permeability through over signaling of the endothelial nitric oxide pathway. The investigators tested the hypothesis that sildenafil would reverse the EOB pattern in patients with HF and pulmonary hypertension.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •consent to participate in the study after detailed information about benefits and risks
- •negative exercise stress test prior to study initiation
- •forced expiratory volume in 1 sec/forced vital capacity ratio >70%;
- •LVEF < 45%.
排除标准
- •inability to complete a maximal exercise test
- •resting systolic blood pressure > 140 or <110 mmHg
- •therapy with nitrate preparations
- •history of sildenafil intolerance
- •significant lung or valvular diseases
- •neuromuscular disorders or peripheral vascular disease
研究组 & 干预措施
Placebo
Control Group
干预措施: Placebo (Drug)
sildenafil, pde5 inhibitor
treatment group; sildenafil 50 mg three times a day for 1 year
干预措施: Sildenafil (Drug)
结局指标
主要结局
Drug Effect on Oscillatory Breathing during Exercise
时间窗: 1 year follow-up
次要结局
未报告次要终点