NCT01014338已完成4 期
ACE-inhibition and Mechanisms of Skeletal Muscle Weakness in Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in phosphorylation of components of the atrogene pathway
研究概览
简要总结
A double blind randomised placebo controlled parallel trial of the effect of fosinopril, an angiotensin converting enzyme inhibitor, on the quadriceps muscle in 80 COPD patients who have quadriceps weakness. Patients will have a baseline assessment including measures of quadriceps strength and endurance and a quadriceps biopsy. Patients with weakness will be randomised to ACE inhibitor or placebo and re-assessed after three months of treatment.
The investigators aim to show that ACE-inhibition will alter the IGF-1/AKT/FoXO/atrogene pathways involved in muscle wasting in COPD.
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
- Double (Participant, Investigator)
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
- •Adult patient with COPD diagnosed according to GOLD criteria.
排除标准
- •Clinically unstable patients (within one month of exacerbation), those with a permanent pacemaker (which is a contraindication to magnetic stimulation), or significant co-morbidity, patients with an accepted indication for ACE inhibition (left ventricular dysfunction, diabetes) or a contraindication such as renovascular disease; creatinine clearance (estimated) <50); hypotension; use of anticoagulants (contra-indication to biopsy) or ACE-I or ATII receptor antagonists.
- •Allergy to ACE-inhibitors.
- •Pregnancy.
- •Patients will not be enrolled within three months of participation in a pulmonary rehabilitation program.
研究组 & 干预措施
ACE-inhibitor
Active Comparator
干预措施: Fosinopril (Drug)
Sugar Pill
Placebo Comparator
干预措施: lactose (Other)
结局指标
主要结局
Changes in phosphorylation of components of the atrogene pathway
时间窗: 3 months
次要结局
- Quadriceps endurance assessed non-volitionally(3 months)
- Effect of ACE-I on quadriceps maximum voluntary contraction force(3 months)
- Effect of ACE-I on quadriceps bulk (cross-sectional area)(3 months)
- Effect of ACE-I on systemic inflammation and serum IGF-1(3 months)
研究者
研究点 (1)
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