Clinical Effect and Tolerability of Atorvastatin Versus Placebo in Patients With Pulmonary Hypertension: Double-blinded, Randomised, Prospective Phase II Study for 6 Months With Adjusted Doses of Atorvastatin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The placebo-corrected change from baseline to week 24 in 6-minute walk distance
研究概览
简要总结
Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary Hypertension: double-blinded, randomised, prospective phase II study for 6 months with adjusted doses of Atorvastatin
详细描述
PAH is characterized by dyspnea, fatigue, and lower extremity edema as a result of heart failure. Several research have proved that inflammation may participate in the pathogenesis of PAH. As atorvastatin inhibits inflammation and has beneficial effects on blood vessels in other types of cardiovascular disease. Therefore, atorvastatin may similarly benefit patients with PAH. Experimental data suggest that statins attenuates pulmonary hypertension in animal experiments. In addition, non-controlled clinical studies suggest that atorvastatin is effective and safe in patients with pulmonary hypertension.
Participants in this study will be randomly assigned to receive 6 months of daily placebo tablets or daily atorvastatin in a double-blind fashion. The study will compare the safety and efficacy of placebo and atorvastatin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and willing to sign the informed consent form
- •<=65 and >=18years old
- •Diagnosis of pulmonary arterial hypertension (Mean pulmonary artery pressure greater than 25 mm Hg at rest with a pulmonary capillary wedge pressure less than 15 mm Hg )that is a) idiopathic, b) familial, or c) associated with connective-tissue disease, d)congenital systemic-to-pulmonary shunt occurring after surgical/interventional repair that had been performed at least five years previously or in the absence of indications for surgery/intervention treatment e) chronic thromboembolism PAH in the absence of indications for surgery
- •Patients in WHO functional class II to III
- •Vasodilator Testing nonresponders
- •Baseline six-minute walking distance between 100 and 460 m
排除标准
- •PAH related to other etiologies (Groups 2, 3 and 5 pulmonary hypertension)
- •A forced expiratory volume in one second/ forced vital capacity bellow 50% or a total lung capacity of less than 60 percent predicted value
- •A 6-minute walk distance of less than 100 or more than 460 m
- •A positive acute vasodilator response
- •Current treatment with calcium-channel blockers or specific therapy (endothelin receptor antagonist, phosphodiesterase-5 inhibitor, or prostacyclin)
- •Inability to perform 6-minute walk test
- •Serum transaminase level three times above the upper limit of normal
- •Creatine kinase level five times above the upper limit of normal
- •Previously diagnosed heart disease such as serious cardiac arrhythmias, unstable angina pectoris, myocardial infarction
- •History of transient ischemia attack or stroke within three months
- •Bleeding disorder
- •Positive pregnancy test or breastfeeding practice
- •History or suspicion of inability to cooperate
研究组 & 干预措施
1
Atorvastatin group: receive atorvastatin 10 mg daily in addition to supportive care
干预措施: Atorvastatin (Drug)
2
Placebo group: receive matching placebo in addition to supportive care.
干预措施: Placebo (Drug)
结局指标
主要结局
The placebo-corrected change from baseline to week 24 in 6-minute walk distance
时间窗: Measured at 6 months
次要结局
- Time from randomization to clinical worsening(Measured at 6 months)
- Change from baseline to week 24 in World Health Organization functional class(measured at 6 monthes)
- Change from baseline to week 24 in Borg dyspnea score(measured at 6 monthes)
- Change from baseline to week 24 in hemodynamic parameters derived from right heart catheterization.(measured at 6 monthes)
研究者
Jianguo He
Professor
Chinese Academy of Medical Sciences, Fuwai Hospital